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Best Practices for Expediting Your Product Development - Featured Image

Best Practices for Expediting Your Product Development

Speed to market is one of the major challenges for medical device companies. So, how can you expedit...
Why Design Verification Matters in Medical Device Design and Development - Featured Image

Why Design Verification Matters in Medical Device Design and Development

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 - Featured Image

5 Tips from MedTech Executives on the Value of Quality

When it comes to making medical devices, quality is key.
Implementing Changes to SaMD under New EU MDR - Featured Image

Implementing Changes to SaMD under New EU MDR

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 - Featured Image

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

Medical device quality and regulatory professionals face changes, challenges, requirements, standard...
Why the FDA Pre-Submission is an Underutilized Tool - Featured Image

Why the FDA Pre-Submission is an Underutilized Tool

“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 - Featured Image

Right-sizing your QMS

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 - Featured Image

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

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

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

When asked whether he hires consultants to help him make investment decisions in the MedTech space, ...
Challenges with Pediatric Medical Devices - Featured Image

Challenges with Pediatric Medical Devices

Challenges continue with the design and development of pediatric medical devices.
13 Tips For Audit Etiquette Every Medical Device Company Should Know - Featured Image

13 Tips For Audit Etiquette Every Medical Device Company Should Know

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 - Featured Image

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

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

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