Ensure medical device safety with comprehensive biocompatibility assessment services

In the medical device industry, ensuring that materials are safe for human use is a critical regulatory requirement, especially under the MDR ((EU) 2017/745).

Complying with EN ISO 10993, the international standard for biological evaluation of medical devices, is essential to assess biocompatibility and minimize risks to patients. At Valicare, we provide specialized consulting services to help manufacturers meet these requirements, ensuring product safety and regulatory compliance.

Our EN ISO 10993 biocompatibility services include:

• Biological risk assessment
  We conduct profound evaluations to identify potential biological risks associated with your device materials, ensuring compliance with EN ISO 10993 standards and regulatory expectations.
• Material characterization
  Our experts help analyze device materials for physical, chemical, and toxicological properties to identify potential interactions with human tissue, a key step in biocompatibility assessment.
• Biocompatibility test planning
  Valicare assists in designing a tailored testing strategy, determining the appropriate in vitro and in vivo tests required to assess cytotoxicity, sensitization, irritation, and more, based on the device's risk classification.
• Regulatory documentation and submission support
  We provide guidance on compiling detailed biocompatibility documentation, including biological evaluation plans, test reports, and risk assessments, ensuring successful submissions to regulatory authorities like the FDA, EU MDR, and others.

• Gap analysis and remediation
  We evaluate your existing biocompatibility data to identify gaps and recommend strategies for remediation to align with current EN ISO 10993 requirements.
• Training and education
  Empower your team with tailored training programs on EN ISO 10993 principles, biological risk management, and compliance best practices, fostering a culture of safety and regulatory excellence.