Services
Historical acceptance is a thing of the past.
Intrinsic Medical Group offers a diverse spectrum of Biological Safety services to fit the needs of a wide range of medical device manufacturers. Our strategies are proven to meet the requirements of modern day foreign body and domestic regulations. Regardless of your market or region of distribution, we can help you succeed. Get in touch with us today to learn more about our services and how Intrinsic Medical Group can work for you.
Biocompatibility
Developing a risk assessment can be an intimidating task. Let Intrinsic Medical assess the risk of your product based on the standard principles outlined within ISO 10993, FDA Guidance and foreign body regulations along with developing a complete Biological Evaluation Assessment for your products.
Reusable Devices
With years of experience working on complex case configurations and containment systems, first hand central processing, and submissions into various markets, Intrinsic Medical Group's experts can guide your reusable device needs into the market quickly and cost effectively.
Sterilization
Assessing single use terminal sterilization is a critical task for all medical device manufacturers. Choosing from EtO, E-beam, Gamma, or even X-ray can lead to production constraints, material incompatibility, and major expenses. Let Intrinsic Medical prepare you for the future and validate your single use implant or device to the method that will serve your needs and growth the best.
Device Cleanliness
At Intrinsic Medical we know the requirements and trends of the industry to ensure devices are clean and patient risk is mitigated. Contact us to find out best processes, how to determine what's needed, and to implement best practices that will ensure clean and safe products.