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By Muna Kebede and Matthias Fink, AKRA Team GmbH | The EU's Medical Device Regulation, which entered into force in 2021, introduced new requirements for clinical and post-market data for medical devices in Europe. As an additional level of scrutiny for specific devices, the Clinical Evaluation Consultation Procedure ensures that notified bodies correctly assess the clinical data. Let's look at what we can learn from the expert panel's first published scientific opinions. |
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By Jim Kasic, Boulder iQ | Biocompatibility testing is a regulatory safety requirement that assures a device and its components are compatible with the biologic environment in which the device will be used. Maintain your critical path to market with these tips. |
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By Eric Hinrichs, senior principal quality engineer (retired), Ethicon, part of the Johnson & Johnson Medical Device Companies | It’s in your best interest to be as rigorous and thorough as possible when testing software that runs your medical device. If a device has a software issue/fault, the patient's life could be in danger. |
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| Annex 1 Compliance Guidelines For Biological Indicator Users | Article | By Crystal Hostler, Mesa Laboratories | Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators. |
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| Look, Ma! I Solved These Wearable Device Challenges | Article | By Aaron Johnson, Accumold | Wearable medical devices bear expectations of medical-grade efficacy, plus consumer-grade comfort and aesthetic appeal. Micro-molded thermoplastic parts help OEMs live up to these expectations. |
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