Medical Device Development
Medical Device development is all about building knowledge on the product’s safety and performance. Our experts in product development, biocompatibility, toxicology and regulatory affairs strive to stay on top of the changing regulatory landscape for medical devices. The multi-disciplinary team within SDS enables our services to encompass combination products (drug-device/biologics-device), medical devices for in-vitro diagnostics or products for which the applicable regulation is unclear.
Based on client’s needs, we can give strategic regulatory advice on when to start building technical documentation and quality management system (QMS) to support the development process and preparations for market applications. We are focused on providing the best expert advice on development plans, standards and guidelines, specific activities and reports, the overall regulatory summary documents, perform GAP assessments on Technical documentation and/or QMS, as well as communicating with the regulatory authorities, such as Notified Bodies.