About us?

Who we are and what we do

As experienced medical industry employees, in the field of design, manufacturing and regulation, distribution and marketing, employees and experts of the competent authorities, notified bodies, the European Commission and consultants, we decided to join forces and create comprehensive services for manufacturers, importers and distributors in the medical industry. Our aim is to act to the full to introduce valuable products – from design through to implementation, registration and then post-marketing activities.

On a daily basis, we provide consultancy services to companies from within and outside the European Union.
As independent experts, we have all performed consulting services in the field:

  • 14 training courses carried out,
  • 10 marketing and distribution activities in the medical industry,
  • 19 quality systems implemented in the medical sector,
  • 87 products placed on the market,
  • 278 audits carried out,
  • 323 notifications and notifications.

After joining forces, we can successfully guide your company through the introduction of a new product and offer you comprehensive services.

Mission

Our mission is to provide the highest quality comprehensive marketing services for products supplied by EU and non-EU organisations. Our ultimate goal is not only to provide full support at the product introduction stage, but also to enable our customers to help them solve their problems effectively in the future.

Vision

Customers trust MDR Regulator as a leading consulting company providing top quality services to all organisations in the medical devices, in vitro diagnostics, dietary supplements and personal protective equipment industry.