Innokas has over 30 years of experience in medical device development, Quality and regulatory matters, and SW development and manufacturing. Using our expertise and long industry background, we offer medical device product and documentation maturity evaluation service to review the existing technical file content against required main standard and regulation requirements as well as maturity of manufacturing specification to be able to source and manufacture the product. Evaluation includes review of following aspects and provides a report defining feedback of seen maturity level, identification of main gaps and recommendation for corrections. These include, technical documentation content and readiness level; product design inputs and requirements; Prototype maturity; Risk management documentation; SW development and documentation; Usability engineering documentation; Verification and validation test documentation; and Manufacturing specifications (drawings, electronics documentation, production work instructions, production test specifications).