About Us
As a specialized MedTech consulting firm, we enable companies with seamless preclinical strategies. With over 20 years of experience.
Our experienced team assists with developing biological evaluation plan (BEP), design extractable/leachable studies, review protocols, screen contract research organization (CROs), represent you in meetings with regulatory agencies and CROs, review protocols, prepare toxicological risk assessments, and assemble a biological evaluation report (BER) — all with a focus on speed, quality, and transparency.
20
+
Years.
Combined Scientific Expertise You Can Trust
190
+
Projects.
Solving Complex Problems and Delivering Tailored Solutions
7
Technical Committees.
Shaping the Future of ISO 10993 Standards as Industry Experts
142
+
Trained.
Educating Medical Device Innovators in Biocompatibility and Chemical Characterization