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Product Development

Tracking Serious Adverse Events for Medical Devices (to Ensure GCP Compliance)

November 24, 2022
Paragraph 64 of the European Medical Device Regulations (Regulation (EU) 2017/745) states that clinical investigations should follow “well-established international guidance... Read More
Product Development

Developing a Regulatory Strategy

November 23, 2022
What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike... Read More
Product Development

What Device Makers Need To Know About Design Verification and Validation

November 21, 2022
Design verification and validation are two essential steps in medical device product development. It’s easy to confuse the two, but there’s a simple way to remember them: Read More
Product Development

Understanding Root Cause Analysis in the CAPA Process

November 20, 2022
Corrective and preventive actions (CAPA) is a cornerstone to ensuring the quality of medical device manufacturing. Perhaps that’s the reason why improper CAPA procedures are... Read More
Product Development

How Does the EU GDPR Impact Medical Device Clinical Trials?

November 17, 2022
Mid 2018, most inboxes were flooded with updates on new privacy policies and data processing agreements. All credit went to the newly applicable European Union (EU) General... Read More
Product Development

We Achieved ISO Certification! Now what?

November 16, 2022
What are ISO 9001 and ISO 27001? Once you have them, what can you do with them? These are the questions you’ll hear Mark Alpert answer in today’s episode. Read More
Establishing a QMS

CAPA Process: Step-by-Step Instructions [+ Free Infographic]

November 15, 2022
The CAPA process is a frequent topic of discussion here at Greenlight Guru, mainly because it’s still such a big issue for medical device companies. Year after year, CAPA... Read More
Establishing a QMS

Ultimate Guide to IVDR for In Vitro Diagnostic Medical Device Companies

November 13, 2022
The global medical device industry is a space where forward thinking meets problem solving, all for the same purpose: to improve the quality of life. However, if you’re going... Read More
Product Development

8 Tips Before Calculating Sample Size in Medical Device Clinical Studies

November 11, 2022
Sample size calculation is important, not only because of industry regulations, but also because of ethical considerations. In this blog, I am going to highlight the... Read More

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