During the early design phases, making informed material and design decisions with biocompatibility input will prevent costly issues later and ensure alignment with functional performance needs as well. Our experts integrate with our design teams to provide foundational guidance to set your project on the right path from day one:
- Material Guidance and Selection
- Initial Risk Identification
- Biocompatibility Strategy Development
- Material Characterization Planning
As your device concept becomes tangible, we help establish comprehensive testing strategies and evaluation frameworks that align with regulatory expectations and your development timeline.
- Biological Evaluation Plan (BEP) Development
- Testing Strategy Definition
- Laboratory Partner Coordination
- Prototype Safety Assessment
This critical phase requires rigorous evaluation and documentation to demonstrate biological safety. Our team ensures thorough assessment across all relevant ISO 10993 endpoints while preparing robust regulatory documentation.
- Biological Evaluation Report (BER) Preparation
- Toxicological Risk Assessment
- ISO 10993 Endpoint Evaluation
- Chemical Characterization Support
- Pathology Laboratory and Services
Successful regulatory approval depends on clear communication and comprehensive documentation. We serve as your expert partner in navigating complex regulatory interactions and submission requirements.
- FDA and Notified Body Communication Support
- Regulatory Documentation Preparation
- Deficiency Letter Response Support
- Global Submission Strategy
Biocompatibility responsibilities continue throughout your device's commercial life. We provide ongoing support for manufacturing changes, lifecycle management, and continuous compliance requirements.
- Change Control Documentation
- Updated Biological Risk Assessments
- Reprocessing and Sterilization Guidance
- Training and Educational Programs
Case Study
Situation
With the transition from Medical Device Directive 93/42/EEC to Medical Device Regulation 2017/745, the client needed support to update their technical documentation, including revisiting their biological risk assessments (BRAs), ensuring the validity of existing tests, planning additional tests, and analyzing the results.
Successes
The Veranex team has provided reliable, consistent, and continuous support over a number of years. Over the course of the support, a total of more than 40 products have been assessed. Following our strategic approach, some of the client’s devices went through the CE certification process and are now compliant with the latest regulations, allowing them to remain available on the EU market.Services by Veranex
The biological safety team at Veranex provided continuous support for updating and writing biological risk assessments for a large number of medical products. The work started with an update to the client’s internal biological safety process (SOP) and template for the redaction of BRAs. Then we assessed the biological safety of various devices. We also provided the necessary training on biocompatibility to ensure the client had a thorough understanding of deliverables and was able to answer questions from notified bodies.Product Development & Engineering
Product Development & Engineering
Integrate biocompatibility considerations early in your design process for optimal outcomes.
Quality Consulting
Quality Consulting
Establish robust quality management systems that integrate seamlessly with your biocompatibility programs.
Regulatory Consulting
Regulatory Consulting
Navigate complex regulatory pathways with expert guidance on FDA and MDR submissions.
Medical Device CRO
Medical Device CRO
Design and execute clinical studies that support your biocompatibility findings with real-world evidence.
