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Tips for Success with IEC 60601 for Electrical Medical Devices - Featured Image

Tips for Success with IEC 60601 for Electrical Medical Devices

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

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

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

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)

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)

  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?

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

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

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 - Featured Image

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

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 - Featured Image

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

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How...
4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them) - Featured Image

4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them)

Effective planning is the key to success for any business but to an even greater degree in the medic...

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