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Product Development

3 Common Problems with Design Controls (and the Solutions)

July 29, 2022
The first time you looked at 21 CFR Part 820.30—FDA’s regulations for design control—you probably thought, “Is that it?” Read More
Product Development

Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

July 27, 2022
After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes.  Read More
Product Development

Integrating Connected Device Data into Your Clinical Study

July 26, 2022
Connected devices are devices that may or may not be approved/cleared medical devices. They can be used in multiple places, e.g., a device that is under investigation itself,... Read More
Product Development

Downstream Effects of Inadequate Complaint Handling

July 24, 2022
Getting a product to market is the number one goal of any MedTech startup. But the job isn’t over once that product is on the market—it’s just the beginning. Read More
Product Development

What are the Distributor Requirements under EU MDR and IVDR?

July 22, 2022
If you read the European Medical Device Regulation (EU MDR) and the European In Vitro Diagnostic Regulation (EU IVDR), you’ll notice that both regulations use the term... Read More
Establishing a QMS

Greenlight Guru Further Extends Commitment to Quality for Customers with Earning Both ISO 9001 and ISO 27001 Certifications

July 21, 2022
The certifications for a Quality Management System and an Information Security Management System provide third-party validation of Greenlight Guru’s operating system and... Read More
Product Development

Guerilla Tactics for Quality Leadership

July 20, 2022
What are guerilla tactics for quality leadership? How do you implement a lean quality management system (QMS) and put requirements in place that are truly required -... Read More
Post-Market Surveillance

Selecting The Ideal PMCF Activity

July 17, 2022
Lack of Guidance Drives Confusion Before the EU MDR, the number of proactive PMCF activities, such as PMCF studies, have been limited to higher risk devices. This is largely... Read More
Product Development

3 Tips for Managing Your Medical Device Design History File

July 15, 2022
Your design history file (DHF) is one of the most critical components of your QMS. That’s because the DHF should contain all the product development documentation for a... Read More

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