Medical Device Quality, Regulatory and Product Development Blog

Submitting a 510(k)? Know What “Substantial Equivalence” Means

By Jon Speer on March 4, 2021

Are you gearing up to submit a 510(k)? If so, you need to have a thorough understanding of what “sub...

Visualizing a Medical Device through Illustrations, Animations, and other Artwork

By Nick Tippmann on March 3, 2021

Imagine using medical illustrations, animations, and other types of artwork to tell the story of a m...

Everything you Need to Know about SaMD from an FDA Perspective

By Nick Tippmann on March 1, 2021

Software as a Medical Device (SaMD) is a growing sector of the medical device industry. If you are i...

How to Use Voluntary Consensus Standards to your Strategic Advantage

By Taylor Brown on February 28, 2021

If we were to say that it’s okay if you don’t follow all relevant standards when you develop your me...

Preparing for Remote and On-Site Inspections and Audits

By Nick Tippmann on February 24, 2021

How can medical device companies be better prepared for remote and on-site inspections and audits? P...

How does EU MDR impact your Quality Management System?

By Nick Tippmann on February 22, 2021

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challe...

Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device?

By Wade Schroeder on February 21, 2021

If your medical device falls under premarket submission criteria, there are three types of 510(k) th...

Virtual Auditing in a Post-COVID World of Digital Compliance

By Nick Tippmann on February 17, 2021

What do auditing and compliance protocols look like during a pandemic? Medical device companies cont...

Why a Visual QMS is So Important for Your Medical Device Company

By Jon Speer on February 16, 2021

How valuable would it be to have a visual representation of your entire QMS and all of its functioni...

Case Study: How Delta Development Fast-tracked R&D Down to a Single Year by Implementing a MDQMS

By Nick Tippmann on February 15, 2021

While the current health crisis has served as a catalyst for innovation for medical device companies...

5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes

By Taylor Brown on February 14, 2021

Your internal quality audits should be much more than a “checkbox” requirement on your compliance to...

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

By Nick Tippmann on February 10, 2021

Keeping a constant pulse on current medical device industry standards for risk management, like ISO ...

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