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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
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
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
Product Development

Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained

January 1, 2023
In both the US and the EU, medical devices may be required to undergo a clinical trial before they can be placed on the market. A clinical trial is a systematic assessment of... Read More
Product Development

5 Steps For Effective Trial Design and Improved Compliance

December 29, 2022
This blog post will address a number of elements which are important for overcoming some of the challenges faced in clinical trials – whether it’s pharmaceutical, medical... Read More
Product Development

How to Verify and Validate SaMD in Different Stages

December 26, 2022
Over the past decade, interest in innovating and commercializing medical devices has significantly increased. Read More
Product Development

Most Popular Medical Device Content in 2022

December 25, 2022
“One heartbeat led us here.” Throughout 2022, this has been our signature rallying cry. Sure, it’s got a nice ring to it, and it doesn’t look too bad on a t-shirt either. But... Read More
Product Development

Optimizing Generation of Clinical Evidence for Medical Devices

December 22, 2022
MEDDEV 2.7/1 revision 4, defines clinical evidence as:"The clinical data and the clinical evaluation report pertaining to a medical device." This is both a simple and valid... Read More

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