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Establishing a QMS

9 Steps to Creating a CAPA Audit Checklist

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
Product Development

The 3 C’s of the EU MDR: Changes, Challenges and Contributions

January 12, 2023
The new European Union Medical Device Regulation (EU MDR) comes with a steep path to compliance. But it also comes with a more effective path to achieving a common goal - 'A... Read More
MedTech Lifecycle Excellence

Fraud in the Healthcare Industry & the Role of Whistleblowers

January 11, 2023
What does the False Claims Act do, and when does it involve medical devices?  Read More
Establishing a QMS

How to Manage the Different CAPA Phases

January 8, 2023
They say eyes are the windows to our innermost selves. If that’s true, then the same should be said for your corrective and preventive action (CAPA) process and the view it... Read More
MedTech Lifecycle Excellence

Auditing the Auditor

January 6, 2023
For some people, audits are terrifying. But today’s guest says you need to learn to love the audit process, and she shares information that can help you do that. Read More
Product Development

5 Tips for Running Effective Internal Quality Audits

January 6, 2023
How did your last internal quality audit go? Internal audits can be a bit of a scramble for some medical device companies.  Read More
Product Development

7 Key Pitfalls To Avoid In MedTech Clinical Data Collection

January 6, 2023
With 10 years of experience in the MedTech field, clinical data experts and co-founders of SMART-TRIAL by Greenlight Guru, Páll Jóhannesson and Jon Bergsteinsson have noticed... Read More
MedTech Lifecycle Excellence

What is MedTech Lifecycle Excellence?

January 5, 2023
Why is the state of MedTech culture and tools the way it is? How should the industry be thinking about moving away from generic compliance and toward MedTech Lifecycle... Read More
Establishing a QMS

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

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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