Medtech start-ups

We help you to develop your medical device

Coming from the same entrepreneurial culture and field as medtech start-ups, we offer tailor-made support to each of these healthcare companies.

We understand our customers' problems, and share the same objectives: to bring their medical devices through to clinical trials and human trials, and then to market. Successfully completing these stages while reducing time-to-market requires numerous processes and technical resources, which our teams have the experience and expertise to master. To simplify your development and your procedures, we work together and support you with complete transparency!

A partnership to solve your problems

Building a roadmap and budgeting

To give you the visibility you need to build your business plan and prepare your fundraising.

Challenge your design choices

To make your medical device ready for mass production according to your requirements (biocompatibility...) and defined cost.

Integrate all technical processes

In order to offer you manufacturing capacity without having to manage investments.

Designing and manufacturing complex DM

By bringing you our expertise in active implants and class III devices, minimally invasive instrumentation, catheterization...

Preparing the HIF and clinical investigations

Preparing clinical batches and ensuring regulatory follow-up (verification, first in human, clinical, etc.).

Ensure transfer to production

Thanks to a certified manufacturing tool, sized according to the evolution of quantities.

Your medical device project from A to Z

Design and development

We provide you with mechatronic, microtechnical, electronic and software solutions for all your medical device R&D requirements, up to and including Class III and active implants.
To do this, we first work to remove the technical barriers to your medical device and check its feasibility, before working together to achieve the first stages of development: POC, prototype, First In Human, clinical and preclinical trials...

Industrialization

We offer support and tailor-made processes to ensure that your medical devices are manufactured in a controlled environment. We validate production processes (IQ/OQ/PQ), define detailed manufacturing instructions and carry out a rigorous risk analysis. Our aim: to industrialize your medical device at a competitive cost and provide flexible production capabilities.

Production

Production is carried out in clean rooms (ISO5 and ISO7) to guarantee the sterility and safety of your devices. We also provide full documentation and monitoring of validated processes to guarantee the quality and conformity of finished products.
To guarantee the success of the production process, we ensure its high quality and compliance with regulatory standards, while adapting it to your company's evolving needs.

Regulatory

We support you in defining your regulatory strategy, in drafting your technical file for CE marking or FDA submission, and in setting up your quality management system (with a view to certification to ISO 13485 and/or 21 CFR part 820). We also provide ongoing support for biocompatibility demonstration and regulatory validation.