Futureproofing Your Medical Device QMS for Global UDI Expansion

The Unique Device Identification (UDI) system was conceived as a means of harmonizing identification of medical devices throughout the distribution chain and at the point of use. UDI is required on labeling for Class II and III devices sold in the US (Class I enforcement begins September 2022), and you are likely aware that it’s coming soon under the EU MDR. Less commonly known is the fact that other countries and regions around the globe are also beginning to require […]

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Monitoring the Performance of Your Medical Device Suppliers

Suppliers are obviously a critical component of your business.  Thus, when things start to go poorly, it’s not just their problem – it’s your problem. There are a variety of reasons why medical device suppliers could get booted from your Approved Supplier List but, quite often, the manufacturer-supplier relationship goes south over issues involving product quality and missed delivery time frames. That’s why ongoing monitoring is so important as a tool to head off serious supply issues. Regardless of how […]

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

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 the right verification method is a risk-based decision and there are a variety of methods available. These include: 100% inspection Sampling inspection Skip-lot testing Assessment of pre-shipment samples […]

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

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 decisions, spot performance issues before they worsen, uncover waste, and facilitate supplier performance. The most effective supplier evaluation programs are risk-based, continuous, supplier supported, cross-functional, visible, and accountable.   […]

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