Medical device manufacturers must ensure the biosafety of their medical implant products to comply with relevant regulations.
Medical implants have intimate contact with the human body for durations lasting a few hours to permanently. As such, they are subject to strict regulations regarding their safety. To sell an implant in the EU, it must have a CE Mark certificate, which verifies that a product is safe and performs as intended. The ISO 10993-1 standard describes the requirements for evaluating and testing the biological safety of all the constituent materials in a medical device product.
Ensuring compliance is no easy task and requires deep knowledge of the factors affecting product safety. From raw material selection to potential impurities introduced during production or from the packaging of the final finished product, there are several ways that implant safety can be compromised and which must be considered.
Our experts can help you ensure implant safety and get them compliant and certified for sale in the EU.
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