Product Approval

From concept through to a finished product, regulatory and quality considerations in the realisation process are of fundamental importance to address and demonstrate the safety and effectiveness of your product for pre-market approvals.

InteRA can assist in the planning and conduct of your New Product Introduction process, providing the necessary standard of data to satisfy market approval requirements, as part of your Technical File.

Services provided include

Clinical Evaluation Reviews
Harmonised standard reviews
Risk assessments
Classification reviews, and product family grouping rationale
Testing and validation (Third party test service provider costs excluded)
Labelling reviews (including UDI)
Instructions for use generation and reviews
Technical file generation
MHRA class 1 registrations
Notified Body CE applications