Regulating Medical Device Virtual Manufacturers: What OBL and PBL Private Labelers Need to Know About the EU MDR

Most companies in the business of private labeling medical devices for sale in the EU are painfully aware that the new EU Medical Device Regulation (2017/745) is about to make their life a lot harder. But in case you were not aware, we’ll break the bad news: EU private labeling is having chest pains and is in the ambulance headed for the hospital. The prognosis is uncertain. A brief recap of the situation The current Medical Devices Directive (MDD 93/42/EEC) […]

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Did You Get What You Paid For? Evaluating Products Purchased from Medical Device Suppliers and Contractors

This is the final installment of a 4-part blog series on supplier management. Read part 1 here. We’ve combined all four posts into one easy-to-read PDF. Download it here. When purchased products arrive at your facility, you need to confirm that they meet the requirements established in your quality agreement. What’s the best way to go about that? First, consider the risk associated with the purchased product and then examine any actions the supplier has already taken to verify compliance. Choosing […]

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On-Site Audit. Desktop Review. Supplier Self-Evaluation. How Should I Evaluate My Medical Device Suppliers?

This is the third installment of a 4-part blog series on supplier management. Read part 1 here. We’ve combined all four posts into one easy-to-read PDF. Download it here. Spotty quality. Price increases. Poor reliability. There are myriad reasons why medical device suppliers go from “approved” to “disqualified” on your Approved Supplier List. Regardless of how many suppliers you have, it’s important (and required) that you monitor their performance and conduct regular evaluations. This will allow you to make informed business […]

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Evaluating Potential Medical Device Suppliers, Getting Them Started, and Implementing Effective Controls

This is the second installment of a 4-part blog series on supplier management. Read Part 1 here. We’ve combined all four posts into one easy-to-read PDF. Download it here. Once you have established what you are purchasing and what type of supplier you need, it’s time to find qualified partners. The goal here is to plan and implement a consistent, risk-based approach for engaging new suppliers. It is important (and required in ISO 13485:2016) for you to have documented procedures, […]

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