Quality and regulatory full-service

The development of Medical Devices and In Vitro Diagnostic Systems entails compliance with a regulatory framework. An understanding of the applicable regulatory framework from the early beginning is essential. Innokas works with companies and academic institutions developing innovative solutions within regulatory frameworks by providing support for all round regulatory compliance according to customer needs. Innokas offers Quality and Regulatory (QARA) services, which involve e.g., medical device qualification and classification according to relevant regulations, Regulatory Roadmaps providing a view to steps needed to be taken to achieve regulatory approvals in chosen market area, and general regulatory support covering development of QMS and technical documentation including risk management, clinical/biological safety evaluations, post-market surveillance planning for all types of electromechanical medical and IVD devices and independent Medical Software’s. The service include also training of personnel in relevant quality and regulatory competence areas, supporting clinical investigation planning and communications with the notified bodies and other regulatory authorities. Innokas has a proven track record on high quality documentation leading into shorter notify body handling times for market approvals. This is a flexible service offering from hourly based consultancy to fixed priced service packages based on the need of a company developing regulated Medical/IVD Devices or Software.