Biocompatibility assessment plays a crucial role in the overall design and development process. It ensures that device materials and design do not lead to adverse reactions when in contact with the human body. Given the intricate nature of immune responses, strategic planning is essential for assessing biocompatibility in medical devices. Understanding how each device component interacts and the potential implications is critical for patient safety and regulatory compliance.
Our experts offer comprehensive, customized support—from planning to testing execution. Our approach prioritizes risk assessment, aiming to identify and mitigate potential risks to ensure that your products are biocompatible and safe to use. We collaborate closely with you to understand your medical device’s specific requirements and develop tailored strategies to address them effectively. Strategies that include:
- Identification of applicable standards and requirements related to target markets.
- Characterization of the materials used in the medical device.
- Risk Assessment of potential biological hazards associated with the intended use of the device,
- Plan and outline the specific tests, test methods, acceptance criteria, sample sizes and testing facilities.
- Analyse and evaluate data to assess the overall biocompatibility of the device
- Implement a Post-market surveillance plan to monitor the biocompatibility of your medical device once it is on the market.
Whether you’re a startup looking for comprehensive regulatory assistance or an established company seeking to enhance your compliance strategy, we’re here to support you every step of the way.
Contact us for further information
QAdvis is a solution-oriented trusted service provider for the medical device and in vitro diagnostic device sector. To enable and maintain global market access, we can with high level of knowhow and expertise within quality management and regulatory affairs support your company to be in compliance with applicable regulations and requirements. QAdvis was founded in 2013 and is based in Sweden. We are certified according to ISO 13485:2016.
