| Date | Title | Description |
| 05.09.2025 | Lingering conflict means angst for startup community | Please subscribe to IBJ to decode this article.
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| 27.08.2024 | Greenlight Guru Announces the Appointment of Ed Holmes as CEO | Greenlight Guru Announces the Appointment of Ed Holmes as CEO
Holmes brings exceptional leadership and SaaS experience to Greenlight Guru.
INDIANAPOLIS, Aug. 27, 2024 /PRNewswire-PRWeb/ -- Greenlight Guru, the leading provider of cloud-base... |
| 12.06.2024 | ETQ, Dassault Systèmes, Siemens, PTC, ComplianceQuest, Intellect, and Rockwell Automation are Leaders in ABI Research's QMS Software Competitive Ranking | NEW YORK, June 12, 2024 /PRNewswire/ -- The new Competitive Assessment by global technology intelligence firm ABI Research provides an in-depth and unbiased examination of the solutions offered by nineteen Quality Management System (QMS) so... |
| 25.03.2024 | Greenlight Guru Wins USA Today Top Workplaces Award for 2024 | Greenlight Guru Wins USA Today Top Workplaces Award for 2024
This achievement underscores the company's role as a leader in both the MedTech industry and in creating an exemplary work culture.
INDIANAPOLIS, March 25, 2024 /PRNewswire-PRWeb/... |
| 18.07.2023 | Greenlight Guru Continues Strong Growth in Q2 2023 Powered by Product Innovation | Greenlight Guru Announces Strong Growth in Q2 2023 Powered by Product Innovation We made great advances in our technology in Q2 and we are now in a position where we can effectively serve large global enterprises
INDIANAPOLIS, Ind. (PRWEB) ... |
| 29.06.2023 | Greenlight Guru Once Again Named the #1 Medical QMS Software by G2 | We are very proud to be once again named by G2 as the #1 QMS software
INDIANAPOLIS, Ind. (PRWEB) June 29, 2023
Greenlight Guru, the leading provider of cloud-based solutions for MedTech companies, announces today that it has once again been... |
| 15.06.2023 | CS MEDICA A/S Secures Future Compliance with New Medical Device Regulation through Signed Contract with Notify Body | CS MEDICA A/S Secures Future Compliance with New Medical Device Regulation through Signed Contract with Notify Body
Thu, Jun 15, 2023 13:26 CET Report this content
CS MEDICA, Pioneering the Transition to MDR, Sign Contract with a Notified B... |
| 06.06.2023 | Greenlight Guru Publishes Independent Study Showing the ROI of eQMS Solutions on MedTech Companies | This will help MedTech executives understand why they need to make this critical investment and the measurable benefits it will have for the company.
INDIANAPOLIS (PRWEB) June 06, 2023
Greenlight Guru, the leading provider of cloud-based so... |
| 01.06.2023 | Greenlight Guru Modernizes Validation Approach to Streamline Software Implementation and Adoption for Medical Device Companies | We’re excited to be modernizing our validation approach at Greenlight Guru because it will allow us to release software faster and improve the pace of innovation without jeopardizing compliance for our customers.
INDIANAPOLIS (PRWEB) June 0... |
| 09.05.2023 | Greenlight Guru Launches AI-Powered Solutions to Enable Better Risk Management for the MedTech Industry | We’ve heard from many of our Medical Device customers that no single solution helps them ensure compliance and consistency throughout their device lifecycle. We set out to fix that with the new Risk Solutions by providing the only ISO 14971... |
| 19.04.2023 | Greenlight Guru Builds Strong Momentum in Q1 2023 as Medical Device Companies Move to Modern Digital Solutions | Q1 2023 has been a great quarter for the Greenlight Guru team and we continue to see strong demand in the market
INDIANAPOLIS (PRWEB) April 19, 2023
Greenlight Guru, the leading provider of cloud-based solutions for MedTech companies, annou... |
| 06.04.2023 | Greenlight Guru Introduces Export API for a Connected Quality Management System | MedTech companies can now connect quality system data with other third-party software.
Greenlight Guru, the leading provider of cloud-based software solutions for MedTech companies, announced the launch of its Export API. The new feature wi... |
| 04.04.2023 | Greenlight Guru Introduces Export API for a Connected Quality Management System | With this release, Greenlight Guru is moving from a ‘closed system’ to a connected system - making it easier to get quality data in and out of our QMS platform.
INDIANAPOLIS (PRWEB) April 04, 2023
Greenlight Guru, the leading provider of cl... |
| 02.03.2023 | Greenlight Guru Introduces Newly Expanded Global Partner Program | We’re focused on solving the challenges unique to MedTech, and the Greenlight Guru Partner Program formalizes how we collaborate with like-minded companies to make that happen.
INDIANAPOLIS (PRWEB) March 02, 2023
Greenlight Guru, the leadin... |
| 01.02.2023 | Greenlight Guru Announces the 2023 True Quality Roadshow | Our mission is to improve the quality of life, and bringing MedTech professionals together to connect and spark new ideas is an essential part of fulfilling that mission.
INDIANAPOLIS (PRWEB) February 01, 2023
Greenlight Guru, the leading p... |
| 30.01.2023 | Greenlight Guru Releases 2023 MedTech Industry Benchmark Report | Built on survey data gathered from over 600 medical device professionals, the study provides a comprehensive and in-depth view into new trends, outlooks, challenges, and opportunities in the MedTech market.
INDIANAPOLIS (PRWEB) January 30, ... |
| 14.12.2022 | Greenlight Guru Surpasses 1,000 Customer Milestone and Continues Rapid Growth | We celebrate our 1,000th customer because we know that with each new customer, we have improved the quality of life for real people - a child, a parent, a co-worker, or a friend.
INDIANAPOLIS (PRWEB) December 14, 2022
Greenlight Guru, the l... |
| 08.12.2022 | Greenlight Guru Appoints Dan Thompson as Chief Sales Officer and Jeff Perkins as Chief Marketing Officer | Dan and Jeff are joining Greenlight Guru as we enter a new chapter of expansion, innovation, and scale.
INDIANAPOLIS (PRWEB) December 08, 2022
Greenlight Guru, the leading provider of cloud-based software solutions for MedTech companies, an... |
| 16.08.2022 | M1 MedTech Accelerator Program Announces First Cohort of Early-Stage Medical Device Companies | M1 combines funding, entrepreneurial advice, expert services, and a one-of-a-kind curriculum to accelerate the next generation of MedTech companies
HOUSTON, TX / ACCESSWIRE / August 16, 2022 / M1 MedTech, a Houston-based early-stage medical... |
| 21.07.2022 | Greenlight Guru Further Extends Commitment to Quality for Customers with Earning Both ISO 9001 and ISO 27001 Certifications | This is our way of assuring customers we will always be capable of delivering secure, high-quality products and services that meet industry regulations and make it easier for them to do the same.
INDIANAPOLIS (PRWEB) July 21, 2022
Greenligh... |
| 16.06.2022 | Greenlight Guru Unveils the World's First MedTech Lifecycle Excellence Platform to Enable Success Across The Entire Product Lifecycle | MedTech professionals deserve better solutions for the challenging, inspiring, life-changing work they do day-to-day.
INDIANAPOLIS (PRWEB) June 16, 2022
Greenlight Guru, pioneer of industry-dedicated MedTech software solutions, officially a... |
| 02.06.2022 | Greenlight Guru Acquires Electronic Data Capture Solution SMART-TRIAL | With the combined experience of Greenlight Guru and SMART-TRIAL and synergies between the platforms, we will be able to provide an offering for MedTech of unprecedented quality and scale.
INDIANAPOLIS (PRWEB) June 02, 2022
Greenlight Guru, ... |
| 24.05.2022 | Greenlight Guru Acquires AI/ML Consultancy Vertex Intelligence | Acquisition of data science company brings artificial intelligence in-house to bolster company’s efforts towards smart MedTech quality |
| 24.05.2022 | Greenlight Guru Acquires AI/ML Consultancy Vertex Intelligence | The acquisition of Vertex Intelligence enables us to help medical device companies achieve True Quality through proactive decision support across the entire medical device product life-cycle.
INDIANAPOLIS (PRWEB) May 24, 2022
Greenlight Gur... |
| 17.03.2022 | Design Controls — The Secret to Better Medical Devices, Upcoming Webinar Hosted by Xtalks | TORONTO (PRWEB) March 17, 2022
Medical device professionals know they must follow specific regulations — some of them even know what those regulations are. But how many professionals know how those regulations can help them be better design... |
| 17.02.2022 | Survey Finds Fewer Than 3% of Pre-Market Medical Device Companies Are Very Effective at Measuring the Results of Quality Initiatives | High-performing companies stand out by viewing quality as more than a compliance effort and injecting quality into product development and supplier management processes.
INDIANAPOLIS (PRWEB) February 17, 2022
Greenlight Guru, pioneer of the... |
| 03.02.2022 | Greenlight Guru Expands Solution to Further Integrate Quality and Product Development Activities | Our Medical Device Success Platform, and the new addition of Greenlight Guru Products, does just that. It allows medical device companies to build, evolve, and innovate upon their products without the worry of siloed and disconnected data.
... |
| 25.01.2022 | Greenlight Guru Announces True Quality 2022, Inaugural Conference for the Medical Device Industry | We are excited about the inaugural True Quality 2022 — a conference for our customers, partners, and the entire medical device community to come together to imagine, introduce, and advance higher-quality devices.
INDIANAPOLIS (PRWEB) Januar... |
| 19.01.2022 | Greenlight Guru Acquires Visual Medical Design Collaboration Solution CanvasGT | I’m especially proud of the acquisition by Greenlight Guru because our shared vision of medical device success protects that strategic focus. Working together ensures delivering the solution to the users so that more life-saving innovations... |
| 19.01.2022 | A fast-growing software company will expand to the Triangle after buying Raleigh startup | RALEIGH, NC, Jan. 19, 2022 /The News & Observer/ – CanvasGT, a Raleigh startup that makes software for medical device designers, has been bought by the Indianapolis company Greenlight Guru, the two companies said Wednesday. |
| 17.11.2021 | Greenlight Guru Launches Guru Assist, On-Demand Lifeline to Medical Device Experts | It is our company's mission to improve the quality of life by helping our customers deliver safe and effective medical devices to patients and clinicians around the world.
INDIANAPOLIS (PRWEB) November 17, 2021
Greenlight Guru, pioneer of t... |
| 23.09.2021 | Greenlight Guru Opens New Global Headquarters in Downtown Indianapolis | Throughout the entirety of the pandemic, our team has continuously worked hard to support our mission of improving the quality of life. We are so excited to invest back into our employees and the Indianapolis community by providing them wit... |
| 20.09.2021 | How to Get Your 510(k) Approved on Your First Try (And Why Only 31% Succeed), Upcoming Webinar Hosted by Xtalks | How can a submission be constructed in a way that’s least likely to be rejected?
TORONTO (PRWEB) September 20, 2021
Did you know that between January and June of 2015, 69% of 510(k) applications were rejected their first time? Even though t... |
| 24.08.2021 | CEO of High-Growth Software Company Places Top 10 in the World in Elite Rowing Competition | Our team works hard and embraces difficult tasks. Sometimes they even surprise themselves when they learn just how capable they are to tackle the emotional hurdles of large challenges.
INDIANAPOLIS (PRWEB) August 24, 2021
Greenlight Guru, p... |
| 17.08.2021 | How to Use Design Controls and Risk Management to Reduce Complaints and CAPAs, Upcoming Webinar Hosted by Xtalks | Participants will learn actionable tips and best practices for optimizing design controls and risk management processes and ways to leverage these practices to improve the overall health of quality management systems (QMS).
TORONTO (PRWEB) ... |
| 16.06.2021 | Greenlight Guru Announces Medical Device HQ Partnership | This partnership is an opportunity for us to meet yet another need of the medical device industry by continuing to make additions to our industry leading suite of software solutions designed to help medical device professionals.
INDIANAPOLI... |
| 16.06.2021 | In private equity, compensation lags for women in senior positions | This is the web version of Term Sheet, a daily newsletter on the biggest deals and dealmakers. Sign up to get it delivered free to your inbox.
In general, 2020 proved to be a good year for private equity dealmakers.
Even as deal value and v... |
| 16.06.2021 | In private equity, compensation lags for women in senior positions | This is the web version of Term Sheet, a daily newsletter on the biggest deals and dealmakers. Sign up to get it delivered free to your inbox.
Paid Content 4 ways CEOs can build a successful cloud strategy From PwC
In general, 2020 proved t... |
| 15.06.2021 | Greenlight Guru Receives Strategic Growth Investment from JMI Equity | New investment will allow the medical device industry’s leading software platform to rapidly expand its product capabilities and support significant global growth |
| 15.06.2021 | Greenlight Guru Receives Strategic Growth Investment from JMI Equity | This partnership will allow us to accelerate the value we provide to our customers as we remain committed to helping medical device companies get their life-changing products to patients and achieve our mission of improving the quality of l... |
| 14.06.2021 | Software-Focused JMI Equity Invests More Than $120 Million in Greenlight Guru | Greenlight Guru, a software provider that helps medical device businesses navigate the regulatory approval process, has received over $120 million from growth investment firm JMI Equity.
The Indianapolis-based company provides cloud-based s... |
| 08.06.2021 | Finding Success, Growth And Wellness Through Self-Hypnosis And Mindset Training | David DeRam, CEO Greenlight Guru and founder of the Progeny FoundationD. DeRam |
| 03.06.2021 | Greenlight Guru Launches Global Medical Device Job Board | Just like generic quality management systems, generic job boards really struggle to meet the needs of high-growth medical device companies. In a time where efficiency and success are critical, we remain committed to providing true quality s... |
| 27.05.2021 | Greenlight Guru Announces the Formation of Its New Regulatory Advisory Board | Greenlight Guru is continuing to push the ideal of harmonization and industry best practices forward through the formation of our Regulatory Advisory Board.
INDIANAPOLIS (PRWEB) May 27, 2021
Greenlight Guru, the leading medical device quali... |
| 15.04.2021 | Greenlight Guru Named Premier QMS Software for NIH RADx Initiative | Our ability to support RADx projects through our focus on medical device quality management for purpose-built solutions and rapid implementation of pre-validated systems is unparalleled in comparison to what other industry players can offer... |
| 08.03.2021 | Greenlight Guru Launches Greenlight Guru Academy as a Trusted Source of Education to the Global Medical Device Community | "With the introduction of Greenlight Guru Academy, we aim to be the worldwide leader in medical device industry education and help our community develop high quality devices for those who depend on it.”
INDIANAPOLIS (PRWEB) March 08, 2... |
| 08.02.2021 | Greenlight Guru Announces True Quality Summit Series: EU MDR & IVDR | The upcoming summit will pull together some of the brightest minds in the industry to share insight and tips to ensure compliance as we take on another year of change.
INDIANAPOLIS (PRWEB) February 08, 2021
Greenlight Guru, the leading medi... |
| 03.02.2021 | Digital.com Names Best Custom Software Developers in Indianapolis | SEATTLE (PRWEB) February 03, 2021
Digital.com, a leading independent review website for small business online tools, products, and services, has announced the best custom software development firms in Indianapolis. The top companies were se... |
| 18.01.2021 | Greenlight Guru Launches Halo℠ For Change Management, World’s First AI & ML Recommendation Engine for Medical Device Quality | Halo℠ for Change Management is the first AI feature that allows you to predict the impact of your change and provides you with recommendations for what is impacted by a change.
INDIANAPOLIS (PRWEB) January 18, 2021
Greenlight Guru, the lead... |
| 05.01.2021 | Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster | We continually work to increase value for our customers and adding partners like Nelson Labs to our global ecosystem of industry relationships is a critical component in that initiative.
INDIANAPOLIS (PRWEB) January 05, 2021
Greenlight Guru... |
| 18.12.2020 | Digital.com Names Best Quality Management Software of 2021 | SEATTLE (PRWEB) December 18, 2020
Digital.com, a leading independent review website for small business online tools, products, and services, has announced the best quality management software of 2021. The top solutions were evaluated based ... |
| 08.12.2020 | Survey Finds On-Site Inspections of Device Makers have Plummeted by 93% as FDA Scrambles To Find Virtual Solutions | "Quality isn’t a department, but a cultural mindset within a business. Quality cannot be treated as a check-the-box activity — unfortunately, even when mandated by law, we’re seeing companies do the bare minimum."
INDIANAPOLIS (PR... |
| 03.02.2020 | Why Great Companies Don't Run On Spreadsheets | Photo:Getty |
| 01.08.2019 | 10+ can't-miss Houston business and innovation events for August | If you subscribe to the idea that your net worth is your network, then here's your guide to networking this month in Houston's innovation ecosystem. August has meetups, pitch nights, and networking aplenty.
If you know of innovation-focused... |
| 31.10.2018 | How the Apple Watch changed the world | In 2015 Switzerland was fucked. This blunt belief, grunted out by Apple’s Jony Ive and repeated by the media as a death knell for the watch industry, seemed to define a sad truth: that the Swiss watch was dead and Apple pulled the trigger.
... |
| 23.04.2018 | A timeline to adopt medical device QMS (and why you need to act now) | I know you’re busy and there’s a lot going on, but I’ve heard some anecdotal evidence to suggest that perhaps as little as only 2 percent of U.S. medical device companies have their certification done already. This came from an auditor at o... |
| 29.03.2018 | Here’s what you need to know about FDA’s new guidance on software as a medical device | Medical devices are a big business covering a wide range of modalities and applications. To ensure the safety of these devices, the Food and Drug Administration (FDA) publishes guidelines and regulations that assess the safety and efficacy ... |
| 21.12.2017 | The potential impact of FDA’s use of PRO to assess effects of medical devices | As with any new report or guidance that comes out, we tend to be concerned with how radical any changes might be and the significance of those changes for the medical device industry. What’s happening? Here’s my take on the new policy:
Focu... |
| 17.10.2017 | How to prepare your medical device company for an FDA inspection | Here are some of the issues that we commonly see medical device companies trip over:
Be prepared! People often hear that an inspection will happen, but don’t really believe it. Inspections are mandated, particularly for Class II or III medi... |
| 21.08.2017 | Debunking 8 commonly held CAPA myths | We often find that companies may hold to any of a few common myths around CAPA, which may impede their progress in some way. Sometimes, we’ll even find that companies are making a huge deal of something that is really not necessary.
Let’s l... |
| 15.06.2017 | What are the best ways to handle medical device customer complaints? | Your complaint handling procedure and CAPA (Corrective Action and Preventive Action) are inter-related. Here’s what you should know:
What’s required?
Of course, as with anything related to medical device development, there are regulatory re... |
| 25.05.2017 | What should trigger a CAPA in medical device manufacturing? | They treat every issue as a CAPA-worthy incident. When this happens, companies can find themselves overburdened with paperwork and are under-resourced to deal with the onslaught of work. We call this “death by CAPA.”
They don’t escalate iss... |
| 13.04.2017 | 4 key compliance issues for medical device companies | The goal for most developers of new medical devices is to get them to market as quickly as possible, right? So, what are some of the factors that commonly put roadblocks in the way?
You’re probably aware that for good reason, the medical de... |
| 03.03.2017 | 5 predictions for the medical device industry | A new FDA Commissioner in 2017
A new president often results in a new FDA commissioner. This election cycle was no different. Dr. Robert Califf resigned his post after Donald Trump took office.
Again, this is not all that unusual when a new... |
| 18.08.2016 | 6 tips to reduce likelihood of a rejection for an FDA 510(k) submission | Is it really that high?
Then I spoke with a couple of other regulatory experts—one who consults with FDA and another who is a former FDA reviewer—who both confirmed that statistic sounds about right.
Have you had similar experiences? What w... |
| 25.07.2016 | Debunking 4 commonly held design control myths | The design control struggle is real.
What is the struggle, you ask?
Design controls are not being used as an aid during medical device product development.
Design controls are being viewed as a checkbox item — something you have to do, and ... |
| 14.07.2016 | Navigating the difficult road of medical device product development while avoiding the common pitfalls | Meet Eddy Engineer. Eddy recently came up with a brand new idea for a medical device.
This “eureka moment” is definitely one of the most exciting feelings in the world. To be a part of developing a new medical device that will help people i... |
| 14.06.2016 | Step-by-step guide to complying with medical device QMS requirements | FDA has published and makes available ALL regulations required for medical device companies. Look them up by searching 21 CFR part 820.
And for outside U.S., you can easily obtain ISO 13485 for a relatively small investment. Make the purcha... |
| 06.06.2016 | Understanding ISO 14971 medical device risk management | Medical device companies MUST have established risk management processes that comply with ISO 14971.
And it doesn’t matter if you are developing medical devices in the U.S., EU, Canada, and so on.
EVERY INTERNATIONAL REGULATORY AGENCY YOU’V... |
| 26.05.2016 | 3 tips for applying risk management across medical device product development | Medical device product development and risk management are often treated as entirely separate processes.
Sure, there is usually acknowledgement and understanding that these two processes are related.
But it is important to realize that prod... |
| 19.05.2016 | What were the top reasons FDA issued device makers 483’s and warning letters in 2015 | FDA Medical Device QS Surveillance Inspections CY2008 – CY2015
(Source: 2015 Annual FDA Medical Device Quality System Data)
Yes, I know that not every med device firm gets inspected every two years.
If FDA showed up today, would you be read... |
| 09.03.2016 | How To Respond to FDA 483s and Warning Letters | Technically, FDA is mandated to inspect any company with class II or class III products every two years.
Yes, I know. You don’t really think FDA is going to show up. Maybe they won’t.
But if they do, don’t you want to know what to expect? Y... |
| 16.12.2015 | An alarming device trend: Why getting 510(k) clearance alone is not enough | But getting that letter from FDA stating you have successfully received market clearance can make it all worth it! An Alarming Trend
During the past several months, I have talked to and worked with dozens and dozens of medical device compan... |
| 30.10.2015 | The beginner’s guide to MedTech design verification and validation | From my product development experiences, entering into Design Verification and Design Validation is always bittersweet.
Exciting because yes, to get to Design Verification means that we have accomplished quite a bit.
Terrifying because the ... |
| 23.09.2015 | The $400,000 FDA compliance mistake you don’t want to make | You would be wrong.
And it might cost your company $400,000 or more to find out.
This is a story I recently heard from a medical device startup who lost over $400,000 dealing with the aftermath of an FDA compliance inspection. The $400k mis... |
| 01.09.2015 | How to improve your medical device startup’s funding chances | However, when you ask entrepreneurs and startups in the medical device industry to define their single biggest challenge, their response is overwhelmingly clear:
Money.
Which kind of stinks. Especially for all those that have a fantastic id... |
| 12.08.2015 | Is your risk management system for medical devices up to date? | If you are still using FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date.
And you might be asking why do you need to abandon FMEA as the risk management tool of c... |
| 05.08.2015 | What’s the best approach to medical device Design Reviews? | The “less is more” and the “more is better”.
Which camp are you in? Design Reviews according to FDA and ISO
As a quick reminder, let me share what is stated about Design Reviews in FDA and ISO.
FDA 820.30(e):
Each manufacturer shall establi... |
| 15.07.2015 | Here’s a look at FDA design controls for medical device developers | What’s this guide about anyway?
Back in 1998, I started my career as a medical device product development engineer.
At that time the FDA Design Controls regulations were still fairly new — not only to me — but the industry in general.
In th... |
| 01.07.2015 | 3 steps to getting your medical device startup off the ground | It’s easy to get bogged down realizing all the stuff you have to do.
But you have to make progress.
And in order to do so, you need some structure.
You need to focus.
It requires discipline.
Before you start every day, you need to ask yours... |
| 22.06.2015 | Regulatory classification 101: A guide to how your medical device will be classified | Regulatory Classification 101
Basically, every medical device is regulated in some way by regulatory agencies, such as FDA, European Commission, and Health Canada. These regulatory agencies have defined a bunch of rules and regulations (or ... |
| 09.06.2015 | What issues draw the most attention in FDA medical device inspections? | Good news.
FDA tells you how they will inspect you in the “Guide to Quality System Inspections,” more collectively known as QSIT.
But have you ever wondered what are the top issues cited during an FDA inspection?
These “issues” are known as... |
| 27.05.2015 | 15 items medical device startups need to address | To help, I’ve put together this quick list for you of 15 items your medical device startup will need to address. #1 – Establish Design Controls / Design & Development Procedures
Refer to FDA 21 CFR 820.30.
Create a procedure that descri... |
| 13.05.2015 | Why medical device startups need to master juggling and balancing with focus | Instead, I’d like to share a few thoughts on balancing and juggling and how these apply to medical device startups. Medical Device Startups Struggle With Balance
Imagine for a moment you are managing a medical device product development pro... |
| 30.04.2015 | 4 medical device quality system musts for startups | A medical device startup should treat the development of a quality management system in a similar fashion as the development of a medical device.
Build your medical device quality system as you go. Bootstrap it!
Why Bootstrapping Works
If y... |
| 16.04.2015 | 2 things you should do asap when starting a medical device project | The project “champion” was an anesthesiologist from Germany, Dietmar Enk. Dr. Enk’s primary language was German, and his English was very good. We were six time zones apart, and email was actually a pretty new thing for the company I was wo... |
| 09.04.2015 | How to run effective medical device design reviews | Still as a product development engineer back in the day, I looked forward to Design Reviews.
Why?
Design Reviews represented a time in my projects when we were one step closer to getting into production and the market. I would be sure to in... |
| 12.02.2015 | greenlight.guru Closes $1.25M Seed Funding | greenlight.guru, an Indianapolis, IN-based quality management software for the medical device community, closed a $1.25m seed funding round.
Backers included a group of undisclosed individual angels.
The company intends to use the capital t... |
| 10.02.2015 | A software support system for medical device developers nets $1.25M in fresh capital | The idea is to simplify compliance for companies looking to bring their products to market. A spokesman for the company said it offers an easy to provide documents supporting design development, quality management and FDA compliance forms. ... |
| - | Regulatory classification 101: A guide to how your medical device will be classified | What I am about to share with you is a guide to medical device regulatory classification.
In this guide, I will provide you with a step-by-step approach for determining how your medical device will be classified by U.S. FDA, European Commis... |
| - | What were the top reasons FDA issued device makers 483’s and warning letters in 2015 | When was your last FDA inspection?
You may believe that the likelihood of an FDA inspection happening to your company is low.
However, medical device companies registered with FDA with class II and class III products are subject to mandator... |
| - | How to run effective medical device design reviews | Design Reviews are intended to be checkpoints in a medical device product development to ensure the product design is safe, effective, and progressing.
Design Reviews are also a way to ensure Design Controls are being captured and documente... |
| - | How to improve your medical device startup’s funding chances | Product development of any kind is challenging and full of unknowns, obstacles and pivots.
Medical device product development is certainly no different.
With med devices, when you throw in regulatory bodies, such as FDA and others internati... |
| - | What should trigger a CAPA in medical device manufacturing? | Over years of working with medical device companies, we’ve found that there is a particular area that is often rife with issues for companies — CAPA (Corrective Action and Preventive Action).
We see a few common threads when it comes to iss... |
| - | Here’s a look at FDA design controls for medical device developers | What’s this guide about anyway?
Back in 1998, I started my career as a medical device product development engineer.
At that time the FDA Design Controls regulations were still fairly new — not only to me — but the industry in general.
In th... |
| - | What’s the best approach to medical device Design Reviews? | Medical device Design Reviews are critical to the success of product development.
So much so that the infamous Design Controls waterfall diagram shows a design review after every major design control stage.
Interestingly, there are a couple... |
| - | 4 medical device quality system musts for startups | Medical device startups have a pile of things to address yet often don’t have the pile of money to take care of everything that is needed.
Because of this, a medical device quality system often gets pushed to the back burner in favor of act... |
| - | Here’s what you need to know about FDA’s new guidance on software as a medical device | Medical devices are a big business covering a wide range of modalities and applications. To ensure the safety of these devices, the Food and Drug Administration (FDA) publishes guidelines and regulations that assess the safety and efficacy ... |
| - | How To Respond to FDA 483s and Warning Letters | Should you ever have an FDA inspection, you’re going to want to know what to do after.
And if you’re a medical device company with class II or class III products registered with FDA, you need to be prepared for an FDA inspection.
Technicall... |
| - | Is your risk management system for medical devices up to date? | If you are still using FMEA as your methodology to capture medical device risk management activities, then your risk management process is out of date.
And you might be asking why do you need to abandon FMEA as the risk management tool of c... |
