Medical Device development is all about building knowledge on the product’s safety and performance. Our experts in product quality and development, biocompatibility, toxicology, clinical evidence, 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.
Correct categorization and classification of your project will define your regulatory demands. SDS will help you get the right start for your project with the correct classification – implementation of MDR in 2021 will mean classification is changed for many product types. Some products who previously were defined as class I projects are now class II and will require approval by notified body before marketing. Getting the fundamental questions right from the start can make all the difference for the success of your project.
At SDS the thought of combination products warms our hearts and brains. With our combined experience in drug- and device development, we can make a real difference for these projects. Some products balance of the edge of drug- and device legislation pending on claims and how the mode of action is viewed. Also, geopgraphic region may come into play. Let SDS guide you on how to reach the market most effectively.
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 and FDA.