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Product Development

How ePRO Can Help Comply with EU MDR Post-Market Surveillance

December 5, 2022
The EU MDR places more focus on Post-Market Surveillance (PMS) and clinical data collection. Since the EU MDR came into force, medical device manufacturers need to keep... Read More
Product Development

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

December 2, 2022
“Intended use” and “indications for use” are two of the easiest terms to confuse in the medical device industry. They’re often used interchangeably, not only because they... Read More
Product Development

Nonconformance (NC) and CAPA: When Should You Use Each Process?

December 2, 2022
Your nonconformance (NC) and Corrective Action and Preventive Action (CAPA) processes are two critical elements within your quality management system. Read More
Product Development

What "Exempt" Means with Respect to Medical Devices & Regulatory

November 30, 2022
How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a... Read More
Product Development

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

November 24, 2022
Paragraph 64 of the European Medical Device Regulations ((EU) 2017/745 Regulation on Medical Devices) states that clinical investigations should follow “well-established... 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

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