REGULATORY AFFAIRS

Biocompatibility assessment

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.

Biocompatibility assessment

Our experts offer comprehensive, customized support—from planning to test 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, including:

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.
Planning and outlining the specific tests, test methods, acceptance criteria, sample sizes and testing facilities.
Analyzing and evaluating data to assess the overall biocompatibility of the device.
Implementing 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.

Regulatory plans

Our experienced professionals help medical device manufacturers develop regulatory plans that support their entire product lifecycle.

Technical documentation

All medical devices must have documentation available to support its compliance to applicable regulations. Aurevia supports you in planning and developing your technical documentation.

Electrical Safety IEC 60601

IEC 60601-1 is the basic international safety standard for medical electrical devices and systems.

Biological Safety ISO 10993

The international standard for the biological safety evaluation process and preparing biological evaluation documentation for medical device manufacturers.

IVDR compliance for in-house developed tests

Laboratories developing IVDs in-house must maintain technical documentation and Quality Management Systems to comply with the IVDR and national law.

IVD performance evaluation

In vitro diagnostic medical device (IVD) regulations are set in the EU In Vitro Diagnostics Regulation (IVDR).

Qualification and classification of medical devices

Our team’s versatile experience and the available tools help in bringing clarity to the most challenging cases.

Medical software

Let our experts help you understand and adhere to medical device software regulations throughout the entire lifecycle.

Risk management ISO 14971

We can help you setup and implement a risk management system and prepare risk management documentation.

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Biocompatibility assessment