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Post-Market Surveillance

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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Product Development

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

Sara Adams
February 1, 2023
The Periodic Safety Update Report (PSUR) is one of the new postmarket surveillance (PMS) activities required by EU MDR and EU IVDR. These new regulations represent a complete... Read More
Post-Market Surveillance

FDA Form 483 Observations and FDA Warning Letters - What’s the Difference?

Etienne Nichols
February 1, 2023
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to have the FDA turning up for an inspection. Read More
Product Development

Computer Systems Validation: How To Avoid FDA Warning Letters C.F.R. 820.70(i)

Chris McHale
January 27, 2023
Computer systems validation (CSV) is a standard regulatory exercise Med Device companies are required to complete. This is not new news. Read More
Post-Market Surveillance

How to Collect PMCF Data for Lower-Class Medical Devices and WETs

Jon Bergsteinsson
January 26, 2023
Post-Market Clinical Follow-up (PMCF) is necessary for maintaining medical device regulatory compliance, and with the EU MDR, clinicians increasingly need to collect PMCF... Read More
Product Development

Understanding the 5 Phases of Medical Device Development

Adnan Ashfaq
January 20, 2023
The purpose of any medical device is to benefit others and improve the quality of life. However, in order to keep patient and user risk at a minimum, authorities have... Read More
Product Development

3 Types of QMS Audits (Plus 3 Tips to Prepare for Them)

Sara Adams
January 15, 2023
The purpose of a QMS audit is to ensure your company has established the appropriate processes and procedures within your quality management system (QMS), and that those... Read More
Product Development

Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered

Etienne Nichols
January 15, 2023
There are plenty of new requirements to be aware of in both the EU Medical Device Regulation (EU MDR) and the EU In Vitro Diagnostic Device Regulation (EU IVDR). Read More
Establishing a QMS

9 Steps to Creating a CAPA Audit Checklist

Etienne Nichols
January 13, 2023
As you conduct internal audits, you may uncover items to address. If these issues are systemic in nature, then these issues are likely candidates for a more thorough... Read More
Establishing a QMS

Tips for Structuring Your Internal Audit Program (and Mistakes to Avoid)

Jon Speer
January 1, 2023
After a refreshing holiday break, there’s one question you need to ask yourself as you head into the new year: Do we have a plan in place for internal auditing this year? Read More

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