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    Medical and Combination Device Questions

Medical & Combination Device Testing - Questions & Answers

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What medical device testing methods do I need to comply with? A test method should follow good logic, planning and start with a risk analysis. Once the failure modes... More

Is biological testing still required for medical devices? The 2018 version of ISO 10993 emphasises risk assessment and chemical understanding. This means that if the combination of chemicals and... More

What is extractables and leachables testing? It is obviously undesirable for a medication or a medical device to introduce unwanted substances to the human body. E&L testing investigates substances... More

Why is EMC testing required for my medical device? Medical equipment must be immune to the influence of reasonable levels of interference from radiated or conducted emissions. That is... More

What is accelerated aging for medical devices? Accelerated ageing is used to avoid lengthy waiting periods before a product can be approved for marketing. A calculator is available here... More