Medical Device Quality, Regulatory and Product Development Blog

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

By Nick Tippmann on May 11, 2021

What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program...

How to Make Your QMS Comply with EU MDR and IVDR

By Etienne Nichols on May 9, 2021

If your company has or is looking to place medical devices on the EU market, you need to know about ...

4 Reasons to Get ISO 27001 Certification

By Wade Schroeder on May 7, 2021

The average data breach costs a company $3.86 million dollars. Perhaps worse than the financial burd...

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

By Nick Tippmann on May 6, 2021

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many devic...

Three Tips for Designing At-Home Monitoring Devices that Deliver Actionable Information

By PA Consulting on May 6, 2021

We’re all seeing it in real time: Healthcare is increasingly shifting from clinical settings to our ...

How SOLIUS Replaced Paper with eQMS to Gain ISO 13485:2016 Certification in Weeks

By Nick Tippmann on May 4, 2021

It can be challenging for small companies to navigate the medical device regulatory pathways, especi...

Managing Business Risk as a Medical Device Company

By Nick Tippmann on May 3, 2021

It's easy to get so wrapped up in the risk management of your medical device that you forget about m...

How to Build Medical Device Usability Testing and Validation into Your Quality System

By Wade Schroeder on May 2, 2021

Medical device usability testing and validation are critical tasks leading up to a medical device’s ...

Waterfall vs. Agile: Battle of the Product Development Methodologies

By Nick Tippmann on April 28, 2021

Are you 'Team Waterfall' or 'Team Agile' for your product development methodology of choice?

For the Love of Internal Auditing

By Nick Tippmann on April 26, 2021

Who loves internal auditing? Probably 99.99 percent of medical device professionals answered “not me...

Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps

By Jesseca Lyons on April 25, 2021

The Abbreviated 510(k) pathway is one more tool to add to your tool belt for bringing a new medical ...

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

By Nick Tippmann on April 21, 2021

What are the similarities and differences between an in vitro diagnostic (IVD) device machine and a ...

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