Engineering and Management

MEDTECH360 supports small and medium-sized MedTech companies in all phases – from the initial idea through to CE marking. Our comprehensive range of services ensures that your product meets all regulatory requirements and is successfully launched on the market.

Contact us today for a no-obligation consultation and find out how we can provide targeted support for your project!

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Our range of services at a glance

Regulatory Affairs Management

We help you with the approval of your products for the European and American markets.

Quality Management

We can consult you or work with you to develop a suitable QM system for your company.

Risk Management & Usability

With the help of sound risk management, we help you to minimize moving targets and application errors.

Technical documentation

We create or review your technical documentation and make is ready for MDR/ FDA

Start-Up Coaching

With our expertise, we help you to avoid technical and strategic mistakes and achieve success faster.

Training

We are happy to pass on our extensive expertise in the field of medical technology to you in the form of training courses.

MEDTECH360 – Engineering and Management

It is our passion to support our customers in all accompanying processes for the successful market launch of a medical device. This includes project management, quality management and audits, risk management, national and international product approvals (CE, FDA), technical documentation, start-up coaching and training.

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