Intrinsic Medical Group
Intrinsic Medical Group is dedicated to providing solutions that ensure patient safety and facilitate the market approval of medical devices. They offer a diverse spectrum of biological safety services, including biocompatibility assessment, reusable device guidance, sterilization validation, and device cleanliness, all tailored to meet modern regulatory standards. Their approach involves developing custom strategies based on industry knowledge, regulatory guidance, and feedback, helping clients navigate complex compliance landscapes efficiently and effectively.
Industries
Nr. of Employees
small (1-50)
Intrinsic Medical Group
Services
Biocompatibility consulting and BEP/BER preparation
Consulting to assess biological risk, design testing strategies, and produce Biological Evaluation Plans and Reports aligned with ISO 10993 and FDA guidance.
Sterilization assessment and validation services
Evaluation and validation of terminal sterilization approaches for single-use devices, including material compatibility and production considerations.
Reusable device reprocessing consultation
Guidance on complex case configurations, containment systems, and central processing to bring reusable devices to market efficiently and cost-effectively.
Device cleanliness and cleaning-process development
Assessment and implementation of cleaning processes and best practices to ensure device cleanliness and mitigate patient risk.
Biocompatibility training and certification
Two-day interactive course with workshops covering ISO 10993, FDA requirements, BEP/BER creation, and optional customization (e.g., E&L); includes certification exam and hybrid delivery options.
Biocompatibility consulting and BEP/BER preparation
Consulting to assess biological risk, design testing strategies, and produce Biological Evaluation Plans and Reports aligned with ISO 10993 and FDA guidance.
Sterilization assessment and validation services
Evaluation and validation of terminal sterilization approaches for single-use devices, including material compatibility and production considerations.
Reusable device reprocessing consultation
Guidance on complex case configurations, containment systems, and central processing to bring reusable devices to market efficiently and cost-effectively.
Device cleanliness and cleaning-process development
Assessment and implementation of cleaning processes and best practices to ensure device cleanliness and mitigate patient risk.
Biocompatibility training and certification
Two-day interactive course with workshops covering ISO 10993, FDA requirements, BEP/BER creation, and optional customization (e.g., E&L); includes certification exam and hybrid delivery options.
Expertise Areas
- Biocompatibility evaluation and reporting
- Sterilization assessment and validation
- Reusable device reprocessing and central sterile processing
- Device cleanliness and contamination control
Key Technologies
- ISO 10993 biological evaluation framework
- Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) methodologies
- Risk-based biological evaluation approaches
- Terminal sterilization methods (EtO, electron-beam, gamma, X-ray)