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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...
Preparing for Remote and On-Site Inspections and Audits - Featured Image

Preparing for Remote and On-Site Inspections and Audits

How can medical device companies be better prepared for remote and on-site inspections and audits? P...
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...
Why a Visual QMS is So Important for Your Medical Device Company - Featured Image

Why a Visual QMS is So Important for Your Medical Device Company

How valuable would it be to have a visual representation of your entire QMS and all of its functioni...
Case Study: How Delta Development Fast-tracked R&D Down to a Single Year by Implementing a MDQMS - Featured Image

Case Study: How Delta Development Fast-tracked R&D Down to a Single Year by Implementing a MDQMS

While the current health crisis has served as a catalyst for innovation for medical device companies...
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...
Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View - Featured Image

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

Keeping a constant pulse on current medical device industry standards for risk management, like ISO ...
How to Create a Quality Management Plan - Featured Image

How to Create a Quality Management Plan

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 - 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

The Greenlight Guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.

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