Metecon Contract R&D for Medical Device Manufacturers
Metecon realises R&D projects in various fields of medical technology. As specialists for the pre-development of medical devices we support our customers with excellent services in the fields of product development, regulatory affairs and automated test equipment.
Doing things right in the early development phases is of crucial importance for the success of the medical product. With over ten years of experience in the pre-development of medical products we lead our customers from the very first idea through the requirements management, functional samples and clinical tests to a fully verified prototype.
Pre-development of medical devices
Specialising in the pre-development of medical devices, we support our customers in answering all questions to get from an idea to a complete product specification. Whether this means building and testing of functional samples (in-vitro or in-vivo) or analysis of regulatory needs, developing a prototype and going into clinical studies, Metecon is the one-stop-shop for the development of medical devices.
Medical device requirements management and usability
Successful R&D projects and creating innovative products are vital to all medical device manufacturers, and understanding your customers’ needs is the key to the success of your medical device. With our optimised requirements management process we enhance the usability of your product, reduce the risk of your R&D investment and increase your market success.
Medical product development support
Our customers have the special knowledge of their own technology. With over ten years of experience in biomedical R&D in various fields of medical technology we have the knowledge of how to develop a medical product. With this background we can quickly dive into the project and support our customers wherever necessary. And when the job is done, the cooperation stops – but the knowledge stays with our customer.
Engineering services for medical device development
With our team of mechanical, electrical and medical engineers we offer:
- Mechanical design (ProEngineer)
- Electrical design (Altium Designer)
- Development and production of functional samples and prototypes
- Development and implementation of customised automated test equipment
Our experience includes:
- Development of surgical equipment
- Design of single use items, e.g. customised tubing systems
- Design of medical amplifiers for different applications
- Data acquisition and handling of sensors
- Fluidic test equipment for characterisation of sensors
- Diagnostic systems
- IIa and IIb medical devices
Together with our partners we are able to manufacture functional samples and prototypes in product quality with lot sizes from one to several hundred.
Regulatory affairs support
Our specialists for regulatory affairs and technical documentation support every step of the product development. Starting with the analysis of risks and essential requirements (ISO 14971, MDD Annex I) and ending with the declaration of conformity we offer all services around the Medical Device Directive. You can engage our services in combination with a development project or as an individual service; to fill knowledge gaps or to add on to your staff to cover load peaks.
Medical device product development
To cover all aspects of medical device product development we have strong partnerships with specialists for:
- Usability design
- Transfer to serial production
- Manufacturing and production
- Market research and reimbursement
- Medical advisor