Covartim - Services
At COVARTIM we are at your side in every step of the way from the early development of your device to its introduction on the market. Our services range from consulting assignments to in-house product development and include tailored-made trainings. We are here to support, reinforce and strenghten your team.
What do you need?
- I am new to the MedTech area.
- I have a project but I do not know how to tackle it.
- I do not know if my product is a medical device.
Thus we are the right partner for you.
At COVARTIM, we are used to work with newcomers to the industry; entrepreneurs, start-ups, spin-offs and healthcare practitioners looking for advices and long term support.
We will put every effort into making you feel comfortable with the MedTech world and helping you become autonomous by giving clear explanations and providing comprehensive trainings.
We can support you with the process to Develop, Test & Validate and Certify your medical solution and to get trained on related topics.
- We turn your idea into a concept.
- We design prototypes.
- We build the set of requirements.
- We produce a development plan.
- We manage the development process.
- We take care of the product documentation.
- We set up the tests plan.
- We manage the tests campaign.
- We get clearance for starting a clinical investigation.
- We establish the route for getting the certification.
- We set up a partial or full quality management system.
- We ensure all applicable standards are followed.
- We create all the documentation for the CE mark or FDA clearance.
- We interact with Notified Bodies and Competent Authorities.
We provide training on:
- Quality
- Regulatory
- Technical topics