Biolink is your trusted navigator of global regulations including the recent changes to the European Union Medical Device Regulations (MDR). Our experts will consult with you to design optimal preclinical testing strategies for successful submission, respond to regulatory inquiries, and support you from product development throughout your product. We have developed a database of reviewer questions, which further enhances our ability to identify new trends, and we quickly pass this learning on to our customers. The objective is always to provide test results that are right the first time and have the highest likelihood of approval.
- Regulatory Consulting Services
Biological Evaluation Test Strategy Plan
A Biological Evaluation Test Strategy is required as part of ISO 10993. Let our knowledgeable and experienced professionals help you prepare your report. Our toxicologists will recommend and summarize an ISO 10993 biocompatibility testing strategy to increase your likelihood of regulatory success.
Biological Evaluation Test Summary
Your report, prepared by a toxicologist, will summarize your ISO 10993 biocompatibility tests, including device details, standards followed, biological endpoints, and chemical characterization and provide an overview of results and device safety under intended clinical use.
Biological Evaluation with Toxicological Risk Assessment
Biolink is your partner in development and throughout your product' lifecycle. We will provide your Toxicological Risk Assessment and ISO 10993 biocompatibility test results and expert summary with solutions to help you manage and mitigate your product's biological risks.
If you have additional questions about the test, or would like to consult with the experts at Biolink, ASK OUR EXPERT