Medical Device Quality, Regulatory and Product Development Blog

Preparing for EU MDR

By Nick Tippmann on November 13, 2019

Do you have a regulatory strategy to help your company prepare for the new European Medical Device R...

Tips for Success with IEC 60601 for Electrical Medical Devices

By Wade Schroeder on November 10, 2019

Does your company develop electrical medical devices? The standard IEC 60601 is different from other...

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

By Nick Tippmann on November 6, 2019

Quality Assurance and Regulatory Affairs (QA/RA) professionals need to keep their finger on the puls...

EU MDR Implementation Guide

By Michael Galliker on November 5, 2019

The European medical device industry will undergo significant changes as a result of the new medical...

How FDA Distinguishes Between Clearance vs. Approval vs. Granted

By Tom Rish on November 3, 2019

As a medical device professional, you are well aware of how much time and effort goes into getting y...

The Ultimate Guide to the EU MDR General Safety and Performance Requirements (GSPR)

By James Gianoutsos and Rod Beuzeval on October 20, 2019

C2DX, Inc. Impresses auditors and Breezes through MDSAP AUDIT After Implementing Medical Device QMS (MDQMS)

By Nick Tippmann on October 17, 2019

Experienced medical device professionals can agree that investing in quality early on and putting ...

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

By Nick Tippmann on October 16, 2019

FDA recently announced its new Safer Technologies Program (STeP), which intends to make medical devi...

7 Tips to Attract Investors and Raise Funds for your Medical Device

By Jon Speer on October 13, 2019

Is your medical device company in the midst of raising funds or planning to begin the process? There...

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

By Nick Tippmann on October 11, 2019

Surgery can be a challenging experience, not only for patients, but their clinicians and caregivers,...

5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company

By Jon Speer on October 6, 2019

As a medical device manufacturer, your quality management system is the heart of your operations.

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

By Nick Tippmann on October 2, 2019

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How...

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