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Common Mistakes That Can Tank Your FDA 510(k) Submission - Featured Image

Common Mistakes That Can Tank Your FDA 510(k) Submission

Do you know the percentage of 510(k)s that are rejected by the FDA the first time? Shockingly, it’s ...
What is Software as a Medical Device (SaMD)? - Featured Image

What is Software as a Medical Device (SaMD)?

Medical devices are a big business covering a wide range of modalities and applications. To ensure t...
Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions - Featured Image

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

The topic of Real-World Evidence is generating a lot of discussion lately, especially after the draf...
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices - Featured Image

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

What Is This CAPA Guide About? As an experienced medical device professional who has worked with doz...
How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers - Featured Image

How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers

Up until the latest revision of MEDDEV 2.7.1 was published on June 29th, 2016, clinical data provide...
How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage) - Featured Image

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage)

Have you ever considered the pros and cons of a PMA vs a 501(k)? Some of the considerations you must...
Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission - Featured Image

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

It can be confusing to know which submission type is the correct one for your particular development...
Debunking 8 Commonly Held CAPA Myths - Featured Image

Debunking 8 Commonly Held CAPA Myths

  CAPA is a source of ongoing issues within medical device companies.
Understanding FDA’s Proposed Conformity Assessment Pilot Program - Featured Image

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Today on the Global Medical Device Podcast, we’ll be talking to Mike Drues, who is a frequent guest ...
8 Tips to Comply With FDA 21 CFR Part 11 - Featured Image

8 Tips to Comply With FDA 21 CFR Part 11

  When it comes to compliance among medical device companies, there is a lot of misleading informati...
EU-MDR and EU-IVDR are live - Here are some important items you should know! - Featured Image

EU-MDR and EU-IVDR are live - Here are some important items you should know!

After almost 10 years of careful deliberations, the new EU regulations on medical devices finally ha...
A Revised Guideline for Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4 - Featured Image

A Revised Guideline for Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4

Editor's Note: This article was originally published by  Florian Tolkmitt on Medium and is being rep...

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