Medical Device Quality, Regulatory and Product Development Blog

Why Design Verification Matters in Medical Device Design and Development

By Nick Tippmann on September 11, 2019

Design verification can be a difficult stage for medical device companies to carry out effectively. ...

5 Tips from MedTech Executives on the Value of Quality

By Jon Speer on September 8, 2019

When it comes to making medical devices, quality is key.

Implementing Changes to SaMD under New EU MDR

By Nick Tippmann on September 4, 2019

Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the ne...

Career Tips for QA/RA Professionals in the Medical Device Industry

By Nick Tippmann on August 28, 2019

Medical device quality and regulatory professionals face changes, challenges, requirements, standard...

Why the FDA Pre-Submission is an Underutilized Tool

By Jon Speer on August 25, 2019

“I wish there was a way for the FDA to give me a feedback about my medical device, prior to submissi...

Right-sizing your QMS

By Nick Tippmann on August 21, 2019

Is your quality management system (QMS) right-sized to fit with the people, processes and purpose of...

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

By Nick Tippmann on August 19, 2019

How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing

By David Amor on August 18, 2019

When asked whether he hires consultants to help him make investment decisions in the MedTech space, ...

Challenges with Pediatric Medical Devices

By Nick Tippmann on August 14, 2019

Challenges continue with the design and development of pediatric medical devices.

13 Tips For Audit Etiquette Every Medical Device Company Should Know

By Taylor Brown on August 11, 2019

I love audits. Seriously! It is a hybrid experience, like a kindergarten show-and-tell with a classi...

Elevating True Quality with Software as a Medical Device for Early Cancer Detection and Treatment

By Nick Tippmann on August 9, 2019

In the U.S. alone, over 80% of the 5,000 biopsies conducted daily come back either falsely negative,...

When Should You Start a QMS?

By Nick Tippmann on August 7, 2019

Early-stage startups often wonder when the right time is to consider a quality management system (QM...

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