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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Accelerate development with integrated design control and risk software.

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Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Posts by Jon Speer

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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About the Author

Jon Speer is a medical device expert with over 20 years of industry experience. Jon knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru to help companies move beyond compliance to True Quality.

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Product Development

22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles

Jon Speer
May 24, 2020
The Greenlight Guru True Quality Virtual Summit is the must-attend experience for medical device quality, regulatory, and product development professionals who drive... Read More
Product Development

EUA 101: What is Emergency Use Authorization and How can my Device get Authorized?

Jon Speer
May 17, 2020
On Saturday, March 28, health care workers in Los Angeles County discovered that the federal government had delivered 170 ventilators that didn’t work. Essential devices... Read More
Product Development

EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic

Jon Speer
May 3, 2020
The EU Medical Device Regulation (MDR) has been a source of stress for medical device companies around the world. Before COVID-19 transformed the industry, there were still... Read More
Product Development

How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends

Jon Speer
May 3, 2020
Medical device companies are among the most important players in the world’s response to COVID-19. Read More
Establishing a QMS

What are the Changes to ISO 14971:2019 & TR 24971?

Jon Speer
April 12, 2020
Proper risk management is a key process throughout the entire life cycle of a medical device. This is the process that enables companies to develop safe and effective... Read More
Product Development

COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health

Jon Speer
April 5, 2020
COVID-19 has thrown the medical community into a frenzy. Hospitals are struggling as the disease spreads faster than companies can produce masks, ventilators, and tests. Read More
Establishing a QMS

4 Emerging Trends in 2020 Backed by Medical Device Industry Experts

Jon Speer
March 29, 2020
Throughout 2020, the medical device industry will see significant changes take flight. Among the biggest of these changes will be Europe's new medical device regulation... Read More
Establishing a QMS

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

Jon Speer
March 22, 2020
With the deadline for compliance with the EU MDR just around the corner, big changes are being made by medical device companies selling in the European Union marketplace.... Read More
Establishing a QMS

[VIDEO] How to Calculate the Cost Of Quality: Building the Business Case for your Medical Device QMS

Jon Speer
February 14, 2020
How can I justify the costs of implementing medical device specific quality management software at my medical device company? What potential revenue can be lost or... Read More

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