Full incubation
The client will supply an idea, prototype or product, and MMC will then develop all the necessary aspects, including regulatory compliance, product refinement and if needed develop the regulatory compliance of the client's company. This is to ensure that the complete project meets the required laws and standards. All in cooperation with the client and fully transparent with all the stakeholders.
Product management
MMC can if required, service a full product management system for the client. Our team can provide CE-marking on the product and get regulatory clearance/approval for the product. We can sell and distribute the products worldwide for you.
Product and QMS development
You as a client can utilize MMC to develop a product and build the Quality Management System. If you have a QMS, MMC can perform a Gap analysis to eventually improve the QMS to a compliant state. In this case MMC can use your QMS and controlled documents to develop both the product and improve your QMS.
Consultancy
Having a team with a profound understanding of Medtech Regulations is vital for successful Product and Quality Management System (QMS) development. MMC possesses the required expertise across all essential areas to support the clients' needs effectively. Whether it's specialized requirements like sterilization, biocompatibility, or other third-party services, MMC benefits from an established network to address these specific needs.
Manufacturing
The organization offers a range of comprehensive services to bring the medical device to life. These services encompass everything from being a mere component supplier to delivering a fully finished medical device that has obtained regulatory approval or clearance.
A few examples of the manufacturing processes the organization provides: