MDSS Consulting GmbH

Who are we?

The roots of MDSS Consulting GmbH go back to MDSS GmbH – an established service provider as an authorized representative and safety officer for manufacturers of medical devices and IVDs as well as a service partner for manufacturers of personal protective equipment or cosmetic products.

MDSS Consulting GmbH was founded as an independent company in 2014 to meet the increasing demands for specialized consulting services. Since then, we have focused specifically on regulatory consulting along the entire product life cycle of medical devices and IVDs – both nationally and internationally.

Today, we assist manufacturers, authorized representatives, importers, and distributors with in-depth expertise, practical solutions, and a clear focus on individual requirements.

We support from the differentiation of other product types, through the classification of the medical devices or IVDs, to clinical evaluation or performance evaluation. The creation of technical documentation and tasks in quality management are our daily challenges. This includes, among other things, support with regulatory questions regarding development, production, and marketing of medical devices worldwide, as well as post-market surveillance (PMS) and vigilance. Conducting internal audits and assisting with external audits and regulatory inspections are also part of our services, where we can draw on our many years of experience.

MDSS Consulting GmbH offers precise and immediate assistance and is also at your side for long-term projects.

Our Values

Our mission is to guide companies safely and efficiently through the regulatory jungle. We rely on solid expertise, practical solutions, clear communication, transparent consulting, and reliable partnership—so you can focus on what matters: innovative and safe products.

Our Expertise

Our team brings many years of experience in the development, approval, and marketing of medical devices—across all company sizes: from dynamic start-ups to globally operating corporations. We combine solid expertise in biology and medical technology with a deep understanding of regulatory requirements—this broad perspective enables us to respond flexibly and purposefully to the individual needs of our clients.

Get to know us – we look forward to hearing from you

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