Pega Medical Inc. services

If you need to know whether your product meets the national and international regulatory requirements for safety and effectiveness, or how it compares to the competition`s products, Pega Medical Services can perform in-vitro biomechanical evaluation of your new product to verify its structural integrity and function, as well as recommend possible modifications. Our technical staff possesses vast expertise in standard and non-standard biomechanical testing, biomaterials` tribology and corrosion, micromotion, fracture mechanics, regulatory issues, and international standards (GMP, AAMI, ANSI, ASTM and ISO for medical devices).

With expertise in the orthopedic, spinal, cardiovascular and dental fields, Pega Medical’s bioengineering services has been offering on-demand engineering to the industry for over 15 years. Our comprehensive approach to product design will accelerate your product development cycle and reduce your time to market.

Regulatory clearance of new medical devices is one of our strengths. Pega Medical Services’ strong technical background, coupled with a solid understanding of US-FDA and Canadian regulatory requirements, has been a key factor in submitting successful pre-market applications. Pega Medical is ISO 13485:2016 and MDSAP certified.

From initial concept to market and everything in between, Pega Medical’s team will guide you through all the steps of product development. Whether you are a physician with a unique product idea, a start-up company overwhelmed by regulatory requirements or a research center looking to bridge the gap between fundamental research and market ready devices, Pega Medical Services is the partner you are looking for. Pega Medial Services’ comprehensive approach to product development will streamline your device to the market while meeting performance, design, regulatory and cost requirements.