Medical devices benefit patients and users by helping to diagnose and treat patients and to prevent diseases, improving quality of life.
Qualified regulatory experts in EU
Leverage the services of a qualified MDR Regulator team to facilitate the introduction of your product into the EU market.
We carry out comprehensive marketing of the product (activities in the field of legal regulations prior to product implementation, participation in the certification process, notification or registration, support in marketing and distribution) for Manufacturers from Poland, the entire European Union, Asia, South America, North America and Africa.
Specialisation in industry
The industries in which we can help your company are:
In vitro diagnostic medical devices, by examining a sample of tissue or body fluids, effectively and safely diagnose a number of diseases or conditions.
Dietary supplements in Polish regulations are significantly different from medicinal products, which affects their scope of application and restrictions.
Personal protective equipment is a product that protects users from mechanical injuries.
MDR Regulator offers a full range of services to enable manufacturers, importers and distributors to bring their products to European markets and ensure continuity and compliance with applicable European law. A company can use the services of MDR Regulator at any stage of marketing a product - from design, through implementation, testing, documentation, certification, registration or notification, to post-marketing - in the distribution, marketing, market surveillance and other activities.