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 need early support.
- 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.
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.
Develop
Develop
- 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.
Test & Validate
Test & Validate
- We set up the tests plan.
- We manage the tests campaign.
- We get clearance for starting a clinical investigation.
Certify
Certify
- 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.
Training
Training
- We provide training on:
- Quality
- Regulatory
- Technical topics
I need to solve specific issues.
- I have got non conformities.
- I need a regulatory assessment for a new product or a design change.
- I am in the middle of MDR/IVDR transition and I am lost.
- I would like to validate my product development plan and costs.
Thus we are the right partner for you.
Our experts are here to advise you and provide support on specific issues. From just a few hours to days, to longer terms, we ensure the work is done correctly by taking an active part in finding solutions and solving problems.
Our team can help you with Quality Assurance-, Regulatory Affairs-, Development-related matters. We also deliver advanced trainings in order to get you up-to-date on a large number of topics.
Thus we are the right partner for you.
Our experts are here to advise you and provide support on specific issues. From just a few hours to days, to longer terms, we ensure the work is done correctly by taking an active part in finding solutions and solving problems.
Our team can help you with Quality Assurance-, Regulatory Affairs-, Development-related matters. We also deliver advanced trainings in order to get you up-to-date on a large number of topics.
Quality Assurance
Quality Assurance
- We perform internal or supplier audits.
- We perform gap analysis.
- We take care of CAPA.
- We upgrade QMS to latests requirements.
Regulatory Affairs
Regulatory Affairs
- We perform regulatory watch.
- We support CE mark or FDA clearance.
- We manage transition to MDR 2017/745 or IVDR 2017/746.
- We assess regulatory impact for products already on the market.
- We support the PMS and Vigilance.
Development
Development
- We perform external reviews.
- We support technical documentation preparation.
- We revise development plan and strategy.
- We set up V&V plan.
- We manage tests campaign.
Training
Training
- We provide training on:
- Quality
- Regulatory
- Technical topics
- Tailored to specific needs
