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About the Author

Benjamin Bancroft is a Medical Device Guru at Greenlight Guru who enjoys working on audits, CAPAs and Root Cause Analysis. He is a Quality and Regulatory Manager who began his career maintaining the QMS for multiple companies as a CAPA and audit SME. He enjoys helping customers successfully navigate regulations to help achieve compliance and aim towards industry best practices for their devices.

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Product Development

Selecting a Notified Body: How to Work with Your New Device Authority

February 1, 2024
Before you can market your product in the European Union, medical device manufacturers must undergo a conformity assessment carried out by a Notified Body (NB) in order to... Read More
Product Development

Ultimate Guide to Supplier Management for Medical Device Companies

November 8, 2023
A medical device is only as good as its parts. Read More
Product Development

Creating a Supplier Scorecard for Medical Device Supplier Management

September 6, 2023
A supplier scorecard is one of the most effective tools medical device manufacturers have for assessing the performance of their suppliers. Read More
Product Development

How To Vet Medical Device Distributors in Multiple Markets

May 15, 2023
The majority of medical device companies, even the relatively big ones, will need third-party distributors to get their devices to market. Read More
Product Development

The Difference Between Managing Product & Services Suppliers in MedTech

November 6, 2022
Both the FDA’s Quality System Regulations and ISO 13485 require medical device manufacturers to implement purchasing controls. The goal of those controls is to ensure that... Read More
Post-Market Surveillance

Approved Supplier List: How To Add Suppliers to Your ASL in 7 Steps

October 23, 2022
Your approved supplier list (ASL) is one of the critical components of medical device supplier management. The ASL is an in-house record of all the suppliers you’ve... Read More
Product Development

Who are the Economic Operators & What Does EU MDR Require of Them?

June 5, 2022
There are four legal entities designated as economic operators under the European Union Medical Device Regulation (EU MDR): Manufacturers Importers Distributors Read More
Clinical Data Collection

Setting up a Clinical Investigation under EU MDR

May 26, 2022
The European Union Medical Device Regulation (EU MDR) defines a clinical investigation as “any systematic investigation involving one or more human subjects, undertaken to... Read More

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