Medical Device Quality, Regulatory and Product Development Blog

How to Create a Quality Management Plan

By Sara Adams on February 9, 2021

Technically speaking, you can launch a product without a quality management plan—but most of your go...

Greenlight Guru Announces True Quality Summit Series: EU MDR & IVDR

By Nick Tippmann on February 8, 2021

Leading MDQMS provider combines global regulatory leadership with original research data to provide ...

Ultimate Guide to Training Management for Medical Device Companies

By Taylor Brown on February 7, 2021

Prioritizing Medical Device Reimbursement During Product Development

By Nick Tippmann on February 3, 2021

Medical device reimbursement is a key consideration that must be well researched, understood, and ma...

Understanding ISO 13485 Training and Competency Requirements

By Tom Rish on February 2, 2021

Are the employees in your medical device company meeting the training and competency requirements of...

5 Key Principles of Total Quality Management

By Taylor Brown on January 31, 2021

It's easy to think of quality as a niche responsibility, requiring only the involvement of those wor...

5 Actionable Lessons Learned from the RADx Initiative by NIH

By Nick Tippmann on January 27, 2021

Rapid Acceleration of Diagnostics (RADx) is an initiative launched by the National Institutes of Hea...

How Does a Medical Device Quality Management System Differ from other QMS Tools?

By Jon Speer on January 26, 2021

Establishing a more efficient and effective quality management system (QMS) has been a recurring que...

Submitting a 510(k)? First Make Sure You Know What 'Substantial Equivalence' Means

By Jon Speer on January 25, 2021

Are you gearing up to submit a 510(k)? If so, you need to have a thorough understanding of what “sub...

Definitive Guide to Change Management for Medical Devices

By Jon Speer on January 22, 2021

In an industry that is ever-evolving, change is inevitable.

What are the Strategic Priorities for CDRH in 2021?

By Nick Tippmann on January 20, 2021

What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) a...

Change Management Process Explained in 6 Easy Steps (+ free template)

By Sara Adams on January 19, 2021

In Prosci’s research, participants were six times more likely to meet project goals by following an ...

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