Assisting your Development Team
Many start-up companies do not have the full overview of the regulatory- and quality management requirements for the design and development of a medical device. Those requirements are quite rigid and requires experience and up-to-date knowledge.
Medical Device Consult can guide your company through your design and development project and find the optimal strategic path to CE-mark, device registration and/or approval outside EU.
Design and development services
- Establishment of design input
- Fulfillment of General Safety and Performance Requirements from the MDR/IVDR
- Identify regulatory requirements for your product, based on intended use
- Establish design verification plans
- Assist in the establishment of a Risk Management file for your device
- Selection and qualification of suppliers
- Liaison with external test institutes for i.e. electrical safety, sterility validation, biocompatibility studies and use- and mechanical testing to be conducted
Establishment and maintenance of Design History File