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How to Use Voluntary Consensus Standards to your Strategic Advantage - Featured Image

How to Use Voluntary Consensus Standards to your Strategic Advantage

If we were to say that it’s okay if you don’t follow all relevant standards when you develop your me...
How does EU MDR impact your Quality Management System? - Featured Image

How does EU MDR impact your Quality Management System?

The new medical device regulation in the European Union (EU MDR) has introduced a host of new challe...
Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device? - Featured Image

Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device?

If your medical device falls under premarket submission criteria, there are three types of 510(k) th...
Virtual Auditing in a Post-COVID World of Digital Compliance - Featured Image

Virtual Auditing in a Post-COVID World of Digital Compliance

What do auditing and compliance protocols look like during a pandemic? Medical device companies cont...
5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes - Featured Image

5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes

Your internal quality audits should be much more than a “checkbox” requirement on your compliance to...
Greenlight Guru Announces True Quality Summit Series: EU MDR & IVDR - Featured Image

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

Leading MDQMS provider combines global regulatory leadership with original research data to provide ...
Ultimate Guide to Training Management for Medical Device Companies - Featured Image

Ultimate Guide to Training Management for Medical Device Companies

Understanding ISO 13485 Training and Competency Requirements - Featured Image

Understanding ISO 13485 Training and Competency Requirements

Are the employees in your medical device company meeting the training and competency requirements of...
How Does a Medical Device Quality Management System Differ from other QMS Tools? - Featured Image

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

Establishing a more efficient and effective quality management system (QMS) has been a recurring que...
How to Use the De Novo Pathway for your Medical Device - Featured Image

How to Use the De Novo Pathway for your Medical Device

Is the De Novo regulatory pathway a viable option to get your medical device to market?
Understanding Change Management and Change Control in the Medical Device Industry - Featured Image

Understanding Change Management and Change Control in the Medical Device Industry

Change is inevitable in the medical device industry. Innovative device companies are at the constant...
6 Benefits of the Best 21 CFR Part 11 Compliant Software - Featured Image

6 Benefits of the Best 21 CFR Part 11 Compliant Software

Nearly every medical device company is subject to software validation requirements, regardless of wh...

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