Medical Device Quality, Regulatory and Product Development Blog

The Clinical Evaluation Literature Review Process: Identifying and Appraising Clinical Data (Part 2 of 4)

By Niki Price on March 25, 2022

A successful clinical evaluation hinges on your ability to find and appraise the data you’ll need to...

Greenlight Guru Consistently Ranked as a Trusted Partner for Leading Medical Device Companies

By Nick Tippmann on March 24, 2022

Greenlight Guru is proud to announce that it has been selected - by users - as the leading QMS for t...

Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs

By Nick Tippmann on March 23, 2022

For many new medical device professionals a bill of materials (BOM) may feel like a big black box. W...

Clinical Evaluation of a Medical Device: Creating a Process and Establishing Equivalency (Part 1 of 4)

By Niki Price on March 20, 2022

To obtain a CE marking and market your medical device in the EU, you’ll first need to perform a clin...

4 Problems (and Solutions) for the Medical Device Supply Chain

By Taylor Brown on March 18, 2022

If you had told me three years ago that supply chain economics and logistics would become a popular ...

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

By Nick Tippmann on March 16, 2022

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the in...

Understanding Technical Documentation in EU Regulations

By Laura Court on March 13, 2022

Generally speaking, technical documentation is the compilation of documents that explains how a prod...

Let The Document Tell The Story: Document Management Best Practices

By Etienne Nichols on March 11, 2022

Good stories follow a 3-act structure: Act 1: Set up Act 2: Conflict Act 3: Resolution “Thanks a lot...

How Medical Device Intellectual Property Protection Varies by Sector

By Nick Tippmann on March 9, 2022

When developing a product in the medical device space, how does intellectual property (IP) protectio...

QMSR (Quality Management System Regulation) Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

By Etienne Nichols on March 2, 2022

On February 23, 2022, FDA released its proposed rule for the new Quality Management System Regulatio...

Human Factors & Risk Management: What's Needed & Why?

By Nick Tippmann on March 2, 2022

Don’t give up on risk management. It’s the backbone of the product development lifecycle and human f...

Your Device is Non-Significant Risk: Now What?

By Laura Court on February 27, 2022

If you need to conduct a clinical investigation of your device before it has received market approva...

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