Medical Device regulatory requirements worldwide  | Medical Device Approval

Attain Medical Device Approval with MDSS Consulting GmbH; bring your medical devices to the world market with ensured product safety and quality.

MDSS works with a team of partners worldwide and offers many years of experience in the interpretation and implementation of regulatory requirements worldwide.

Thanks to our consulting services, we guide your company safely though the jungle of laws, standards, directives and regulations.

MDSS Consulting GmbH combines a high-qualified team of biologists, engineers, technicians, medical experts as well as social and economic science professionals. We offer you support in areas like the delimitation from other device types and the classification of medical devices or IVDs through to the clinical evaluation or performance evaluation. The creation of technical documentation and quality management related tasks – through the support with regulatory issues regarding development, production and placing on the market of medical devices worldwide – are our everyday challenges. MDSS Consulting GmbH is able to provide not only precise urgent assistance but also long-term consulting projects.