Medical Device Quality, Regulatory and Product Development Blog | Greenlight Guru

Navigating the Twists and Turns of Change Management for Medical Devices

By Nick Tippmann on December 28, 2019

Change is constant… Especially in the medical device industry. Medical device change management can ...

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

By Nick Tippmann on December 18, 2019

FDA announced the anticipated 2020 launch of a new pilot program known as the Accreditation Scheme f...

5 Myths about QA/RA Recruiting in the Medical Device Industry

By Nick Tippmann on December 11, 2019

Recruiting top, elite quality assurance and regulatory affairs (QA/RA) talent in the medical device ...

How to Solve the Medtech Value Equation with Quality Data

By Nick Tippmann on December 4, 2019

Which medical technology, product, or device are you actively focused on bringing to market that wil...

Why Supplier Quality Management Is So Important

By Nick Tippmann on November 27, 2019

Effectively managing suppliers, vendors, consultants, and other third party entities that provide pr...

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...

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...

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...

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...

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...

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

By Nick Tippmann on September 25, 2019

Do you know everything there is to know about prototyping, product iteration, and manufacturing to g...

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. ...

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