Biocompatibility Testing Programs

Regulatory and Technical Associates, Inc. (RTA) is a consulting company that specializes in the design, interpretation, reporting and regulatory submission of biocompatibility testing programs for medical devices. All programs are designed to meet both FDA and ISO 10993-1 requirements. Our consultants are Board Certified in Toxicology, Regulatory Affairs and Safety, and have years of experience in designing and implementing biocompatibility testing programs. We work with clients both internationally and domestically and provide superior, consulting service to our clients in support of biocompatibility testing programs for medical devices.

Our consultants have extensive experience in biocompatibility program design, implementation, conduct, data interpretation, monitoring and reporting.  Regardless of whether your testing calls for a single study or entire testing programs to support your regulatory submission, RTA has the experience to address your needs working with an approved Contract Research Organization (CRO) or with your own in-house testing facility.

We routinely assist our clients with any and all phases of study and program conduct including bid preparation, protocol development, CRO selection, study implementation, GLP compliance, GLP and scientific monitoring of ongoing studies, data review, draft and final report review and regulatory submission.  In addition, RTA is also able to provide extensive report writing and regulatory submission capability.

RTA has the necessary experience in biocompatibility testing to assist our clients’ in addressing the product development safety and regulatory issues that directly impact their ability to bring their medical devices to market.

For more information regarding how we can assist you with your biocompatibility testing programs for medical devices please contact Dr. Robert J. Staab (phone: 860-434-5872; email: rta1ali1@aol.com) or Dr. Ira Daly (phone: 908-236-6834; email: idaly61127@aol.com).