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FDA is Expanding its Case for Quality Program... Should Your Company Participate? - Featured Image

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

By Nick Tippmann on November 20, 2019
Depending on the level of quality and compliance, medical devices can impact patients’ lives for bet...
Definitive Guide to Change Management for Medical Devices - Featured Image

Definitive Guide to Change Management for Medical Devices

By Jon Speer on November 17, 2019
Preparing for EU MDR - Featured Image

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 - Featured Image

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 - Featured Image

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 - Featured Image

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 - Featured Image

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) - Featured Image

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) - Featured Image

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? - Featured Image

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 - Featured Image

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 - Featured Image

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,...

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