Date | Title | Description | Source |
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 compan... | prweb.com/... |
18.07.2023 | Greenlight Guru Continues Strong Growth in Q2 2023 Powered b... | Greenlight Guru Announces Strong Growth in Q2 2023 Powered by Product Innovation We made great advan... | prweb.com/... |
29.06.2023 | Greenlight Guru Once Again Named the #1 Medical QMS Software... | We are very proud to be once again named by G2 as the #1 QMS software
INDIANAPOLIS, Ind. (PRWEB) Jun... | prweb.com/... |
15.06.2023 | CS MEDICA A/S Secures Future Compliance with New Medical Dev... | CS MEDICA A/S Secures Future Compliance with New Medical Device Regulation through Signed Contract w... | news.cisio... |
06.06.2023 | Greenlight Guru Publishes Independent Study Showing the ROI ... | This will help MedTech executives understand why they need to make this critical investment and the ... | prweb.com/... |
01.06.2023 | Greenlight Guru Modernizes Validation Approach to Streamline... | We’re excited to be modernizing our validation approach at Greenlight Guru because it will allow us ... | prweb.com/... |
09.05.2023 | Greenlight Guru Launches AI-Powered Solutions to Enable Bett... | We’ve heard from many of our Medical Device customers that no single solution helps them ensure comp... | prweb.com/... |
19.04.2023 | Greenlight Guru Builds Strong Momentum in Q1 2023 as Medical... | Q1 2023 has been a great quarter for the Greenlight Guru team and we continue to see strong demand i... | prweb.com/... |
06.04.2023 | Greenlight Guru Introduces Export API for a Connected Qualit... | MedTech companies can now connect quality system data with other third-party software.
Greenlight Gu... | aithority.... |
04.04.2023 | Greenlight Guru Introduces Export API for a Connected Qualit... | With this release, Greenlight Guru is moving from a ‘closed system’ to a connected system - making i... | prweb.com/... |
02.03.2023 | Greenlight Guru Introduces Newly Expanded Global Partner Pro... | We’re focused on solving the challenges unique to MedTech, and the Greenlight Guru Partner Program f... | prweb.com/... |
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 connec... | prweb.com/... |
30.01.2023 | Greenlight Guru Releases 2023 MedTech Industry Benchmark Rep... | Built on survey data gathered from over 600 medical device professionals, the study provides a compr... | prweb.com/... |
14.12.2022 | Greenlight Guru Surpasses 1,000 Customer Milestone and Conti... | We celebrate our 1,000th customer because we know that with each new customer, we have improved the ... | prweb.com/... |
08.12.2022 | Greenlight Guru Appoints Dan Thompson as Chief Sales Officer... | Dan and Jeff are joining Greenlight Guru as we enter a new chapter of expansion, innovation, and sca... | prweb.com/... |
16.08.2022 | M1 MedTech Accelerator Program Announces First Cohort of Ear... | M1 combines funding, entrepreneurial advice, expert services, and a one-of-a-kind curriculum to acce... | accesswire... |
21.07.2022 | Greenlight Guru Further Extends Commitment to Quality for Cu... | This is our way of assuring customers we will always be capable of delivering secure, high-quality p... | prweb.com/... |
16.06.2022 | Greenlight Guru Unveils the World's First MedTech Lifecycle ... | MedTech professionals deserve better solutions for the challenging, inspiring, life-changing work th... | prweb.com/... |
02.06.2022 | Greenlight Guru Acquires Electronic Data Capture Solution SM... | With the combined experience of Greenlight Guru and SMART-TRIAL and synergies between the platforms,... | prweb.com/... |
24.05.2022 | Greenlight Guru Acquires AI/ML Consultancy Vertex Intelligen... | Acquisition of data science company brings artificial intelligence in-house to bolster company’s eff... | jmi.com/gr... |
24.05.2022 | Greenlight Guru Acquires AI/ML Consultancy Vertex Intelligen... | The acquisition of Vertex Intelligence enables us to help medical device companies achieve True Qual... | prweb.com/... |
17.03.2022 | Design Controls — The Secret to Better Medical Devices, Upco... | TORONTO (PRWEB) March 17, 2022
Medical device professionals know they must follow specific regulatio... | prweb.com/... |
17.02.2022 | Survey Finds Fewer Than 3% of Pre-Market Medical Device Comp... | High-performing companies stand out by viewing quality as more than a compliance effort and injectin... | prweb.com/... |
03.02.2022 | Greenlight Guru Expands Solution to Further Integrate Qualit... | Our Medical Device Success Platform, and the new addition of Greenlight Guru Products, does just tha... | prweb.com/... |
25.01.2022 | Greenlight Guru Announces True Quality 2022, Inaugural Confe... | We are excited about the inaugural True Quality 2022 — a conference for our customers, partners, and... | prweb.com/... |
19.01.2022 | Greenlight Guru Acquires Visual Medical Design Collaboration... | I’m especially proud of the acquisition by Greenlight Guru because our shared vision of medical devi... | prweb.com/... |
19.01.2022 | A fast-growing software company will expand to the Triangle ... | RALEIGH, NC, Jan. 19, 2022 /The News & Observer/ – CanvasGT, a Raleigh startup that makes softwa... | jmi.com/a-... |
17.11.2021 | Greenlight Guru Launches Guru Assist, On-Demand Lifeline to ... | It is our company's mission to improve the quality of life by helping our customers deliver safe and... | prweb.com/... |
23.09.2021 | Greenlight Guru Opens New Global Headquarters in Downtown In... | Throughout the entirety of the pandemic, our team has continuously worked hard to support our missio... | prweb.com/... |
20.09.2021 | How to Get Your 510(k) Approved on Your First Try (And Why O... | How can a submission be constructed in a way that’s least likely to be rejected?
TORONTO (PRWEB) Sep... | prweb.com/... |
24.08.2021 | CEO of High-Growth Software Company Places Top 10 in the Wor... | Our team works hard and embraces difficult tasks. Sometimes they even surprise themselves when they ... | prweb.com/... |
17.08.2021 | How to Use Design Controls and Risk Management to Reduce Com... | Participants will learn actionable tips and best practices for optimizing design controls and risk m... | prweb.com/... |
16.06.2021 | In private equity, compensation lags for women in senior pos... | This is the web version of Term Sheet, a daily newsletter on the biggest deals and dealmakers. Sign ... | fortune.co... |
16.06.2021 | In private equity, compensation lags for women in senior pos... | This is the web version of Term Sheet, a daily newsletter on the biggest deals and dealmakers. Sign ... | fortune.co... |
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... | prweb.com/... |
15.06.2021 | Greenlight Guru Receives Strategic Growth Investment from JM... | New investment will allow the medical device industry’s leading software platform to rapidly expand ... | jmi.com/gr... |
15.06.2021 | Greenlight Guru Receives Strategic Growth Investment from JM... | This partnership will allow us to accelerate the value we provide to our customers as we remain comm... | prweb.com/... |
14.06.2021 | Software-Focused JMI Equity Invests More Than $120 Million i... | Greenlight Guru, a software provider that helps medical device businesses navigate the regulatory ap... | wsj.com/ar... |
08.06.2021 | Finding Success, Growth And Wellness Through Self-Hypnosis A... | David DeRam, CEO Greenlight Guru and founder of the Progeny FoundationD. DeRam | forbes.com... |
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 o... | prweb.com/... |
27.05.2021 | Greenlight Guru Announces the Formation of Its New Regulator... | Greenlight Guru is continuing to push the ideal of harmonization and industry best practices forward... | prweb.com/... |
15.04.2021 | Greenlight Guru Named Premier QMS Software for NIH RADx Init... | Our ability to support RADx projects through our focus on medical device quality management for purp... | prweb.com/... |
08.03.2021 | Greenlight Guru Launches Greenlight Guru Academy as a Truste... | "With the introduction of Greenlight Guru Academy, we aim to be the worldwide leader in medical... | prweb.com/... |
08.02.2021 | Greenlight Guru Announces True Quality Summit Series: EU MDR... | The upcoming summit will pull together some of the brightest minds in the industry to share insight ... | prweb.com/... |
03.02.2021 | Digital.com Names Best Custom Software Developers in Indiana... | SEATTLE (PRWEB) February 03, 2021
Digital.com, a leading independent review website for small busine... | prweb.com/... |
18.01.2021 | Greenlight Guru Launches Halo℠ For Change Management, World’... | Halo℠ for Change Management is the first AI feature that allows you to predict the impact of your ch... | prweb.com/... |
05.01.2021 | Greenlight Guru and Nelson Labs Announce Strategic Alliance ... | We continually work to increase value for our customers and adding partners like Nelson Labs to our ... | prweb.com/... |
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 busine... | prweb.com/... |
08.12.2020 | Survey Finds On-Site Inspections of Device Makers have Plumm... | "Quality isn’t a department, but a cultural mindset within a business. Quality cannot be treate... | prweb.com/... |
03.02.2020 | Why Great Companies Don't Run On Spreadsheets | Photo:Getty | forbes.com... |
01.08.2019 | 10+ can't-miss Houston business and innovation events for Au... | If you subscribe to the idea that your net worth is your network, then here's your guide to networki... | houston.in... |
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 t... | techcrunch... |
23.04.2018 | A timeline to adopt medical device QMS (and why you need to ... | I know you’re busy and there’s a lot going on, but I’ve heard some anecdotal evidence to suggest tha... | medcitynew... |
29.03.2018 | Here’s what you need to know about FDA’s new guidance on sof... | Medical devices are a big business covering a wide range of modalities and applications. To ensure t... | medcitynew... |
21.12.2017 | The potential impact of FDA’s use of PRO to assess effects o... | As with any new report or guidance that comes out, we tend to be concerned with how radical any chan... | medcitynew... |
17.10.2017 | How to prepare your medical device company for an FDA inspec... | Here are some of the issues that we commonly see medical device companies trip over:
Be prepared! Pe... | medcitynew... |
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 the... | medcitynew... |
15.06.2017 | What are the best ways to handle medical device customer com... | Your complaint handling procedure and CAPA (Corrective Action and Preventive Action) are inter-relat... | medcitynew... |
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 o... | medcitynew... |
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,... | medcitynew... |
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 electio... | medcitynew... |
18.08.2016 | 6 tips to reduce likelihood of a rejection for an FDA 510(k)... | Is it really that high?
Then I spoke with a couple of other regulatory experts—one who consults with... | medcitynew... |
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 us... | medcitynew... |
14.07.2016 | Navigating the difficult road of medical device product deve... | Meet Eddy Engineer. Eddy recently came up with a brand new idea for a medical device.
This “eureka m... | medcitynew... |
14.06.2016 | Step-by-step guide to complying with medical device QMS requ... | FDA has published and makes available ALL regulations required for medical device companies. Look th... | medcitynew... |
06.06.2016 | Understanding ISO 14971 medical device risk management | Medical device companies MUST have established risk management processes that comply with ISO 14971.... | medcitynew... |
26.05.2016 | 3 tips for applying risk management across medical device pr... | Medical device product development and risk management are often treated as entirely separate proces... | medcitynew... |
19.05.2016 | What were the top reasons FDA issued device makers 483’s and... | FDA Medical Device QS Surveillance Inspections CY2008 – CY2015
(Source: 2015 Annual FDA Medical Devi... | medcitynew... |
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 ye... | medcitynew... |
16.12.2015 | An alarming device trend: Why getting 510(k) clearance alone... | But getting that letter from FDA stating you have successfully received market clearance can make it... | medcitynew... |
30.10.2015 | The beginner’s guide to MedTech design verification and vali... | From my product development experiences, entering into Design Verification and Design Validation is ... | medcitynew... |
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 r... | medcitynew... |
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 sing... | medcitynew... |
12.08.2015 | Is your risk management system for medical devices up to dat... | If you are still using FMEA as your methodology to capture medical device risk management activities... | medcitynew... |
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 ... | medcitynew... |
15.07.2015 | Here’s a look at FDA design controls for medical device deve... | What’s this guide about anyway?
Back in 1998, I started my career as a medical device product develo... | medcitynew... |
01.07.2015 | 3 steps to getting your medical device startup off the groun... | It’s easy to get bogged down realizing all the stuff you have to do.
But you have to make progress.
... | medcitynew... |
22.06.2015 | Regulatory classification 101: A guide to how your medical d... | Regulatory Classification 101
Basically, every medical device is regulated in some way by regulatory... | medcitynew... |
09.06.2015 | What issues draw the most attention in FDA medical device in... | Good news.
FDA tells you how they will inspect you in the “Guide to Quality System Inspections,” mor... | medcitynew... |
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... | medcitynew... |
13.05.2015 | Why medical device startups need to master juggling and bala... | Instead, I’d like to share a few thoughts on balancing and juggling and how these apply to medical d... | medcitynew... |
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 fa... | medcitynew... |
16.04.2015 | 2 things you should do asap when starting a medical device p... | The project “champion” was an anesthesiologist from Germany, Dietmar Enk. Dr. Enk’s primary language... | medcitynew... |
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?
De... | medcitynew... |
12.02.2015 | greenlight.guru Closes $1.25M Seed Funding | greenlight.guru, an Indianapolis, IN-based quality management software for the medical device commun... | finsmes.co... |
10.02.2015 | A software support system for medical device developers nets... | The idea is to simplify compliance for companies looking to bring their products to market. A spokes... | medcitynew... |
- | 3 tips for applying risk management across medical device pr... | Medical device product development and risk management are often treated as entirely separate proces... | medcitynew... |
- | Step-by-step guide to complying with medical device QMS requ... | Medical device companies, listen up. There is zero excuse for not complying with medical device qual... | medcitynew... |
- | Navigating the difficult road of medical device product deve... | The story I’m about to tell you is about Eddy Engineer and his trials and tribulations of bringing a... | medcitynew... |
- | How to prepare your medical device company for an FDA inspec... | The FDA has arrived at your premises. What is your reaction? Are you ready?
If you’re lucky, the FDA... | medcitynew... |
- | Debunking 4 commonly held design control myths | The design control struggle is real.
What is the struggle, you ask?
Design controls are not being us... | medcitynew... |
- | 15 items medical device startups need to address | As a medical device startup, there are many things you are juggling and balancing all day, every day... | medcitynew... |
- | What are the best ways to handle medical device customer com... | Let’s say, your medical device business has received a complaint from a customer.
It happens to all ... | medcitynew... |
- | A timeline to adopt medical device QMS (and why you need to ... | To be blunt, if your company has put off doing anything about ISO 13485:2016, you need to act immedi... | medcitynew... |
- | 3 steps to getting your medical device startup off the groun... | Imagine for a moment that you are a medical device startup.
There are probably thousands of things y... | medcitynew... |
- | 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 tha... | medcitynew... |
- | 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... | medcitynew... |
- | 2 things you should do asap when starting a medical device p... | It’s hard to believe I’ve been in the medical device industry since 1998. I have learned so much and... | medcitynew... |
- | 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 d... | medcitynew... |
- | What were the top reasons FDA issued device makers 483’s and... | When was your last FDA inspection?
You may believe that the likelihood of an FDA inspection happenin... | medcitynew... |