Medical Device Quality, Regulatory and Product Development Blog

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

By Nick Tippmann on December 23, 2020

Are you prepared for the aftermath of the pandemic’s impact on the medical device industry? It may b...

Most Popular Medical Device Content in 2020 from Greenlight Guru

By Nick Tippmann on December 20, 2020

Thank you for helping make 2020 another exciting and record-breaking year for Greenlight Guru!

Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

By Nick Tippmann on December 16, 2020

The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficu...

6 Benefits of the Best 21 CFR Part 11 Compliant Software

By Jon Speer on December 13, 2020

Nearly every medical device company is subject to software validation requirements, regardless of wh...

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

By Nick Tippmann on December 9, 2020

Still seeking guidance to stay in the know when it comes to new and updated FDA requirements related...

2021 State of Medical Device Quality Management and Product Development Benchmark Report

By Nick Tippmann on December 8, 2020

Findings of a 2021 industry benchmark survey reveal internal divides within organizations are making...

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

By Nick Tippmann on December 2, 2020

Software as a Medical Device (SaMD) is one of the fastest growing segments of the medical device ind...

What is the True Cost of Poor Quality for Your Medical Device Company? (Free Infographic)

By Tom Rish on December 1, 2020

For a lot of medical device companies, quality management can be a vexing issue. How much is enough?...

What Goes into Designing Devices for Military and Emergency Applications?

By Nick Tippmann on November 25, 2020

There’s one niche market within the device industry that rarely gets the attention it deserves: prod...

12 Medical Device Experts Offer Best Tips for How to Succeed in 2021

By Jon Speer on November 24, 2020

How will COVID-19, new regulatory programs and changes, and technological advancements impact your m...

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

By Taylor Brown on November 23, 2020

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

By Nick Tippmann on November 18, 2020

Some sources claim that one-third of your product development project should be spent on defining go...

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