Your trusted consultancy partner in the medical industry

Use the services of a qualified team of consultants and place your product on the market today

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MDR Regulator – your trusted consultancy partner in the medical industry

We will help your business enter the European market of medical devices and equipment. We will propose solutions allowing you to place the product on the market, including: legal representation as an Authorised Representative in Europe, Person Responsible for Regulatory Compliance, documentation review, product registration, distribution and marketing support in the EU market.

We will guide you through the full process of placing products on the market in EU countries, including:

Medical
devices

In vitro diagnostic medical devices

Food
supplements

Why choose MDR Regulator?

We meet all the requirements and hold a number of ISO certificates necessary to provide consulting services for the medical industry.

What do we offer?

MDR Regulator offers a full range of services enabling medical device manufacturers to place their products on European markets and to ensure continuity and compliance of their operations with applicable European laws.

Our services

EU Authorised Representative

Person Responsible for Regulatory Compliance in accordance with MDR

Post-market surveillance

Additional services

Values of MDR Regulator

As a company that contributes to building one of the most important sectors of the economy, we are guided by the principles of transparency and honesty in our work with clients.

Honesty and transparency

Our work with clients is based on such values as:

  • building long-term relations based on clear and transparent rules of cooperation,
  • responsibility for the decisions made,
  • ensuring competitive advantage,
  • using all possible development tools,
  • taking up challenges.

Learning by doing

By listening to our clients’ needs, we are able to continuously expand our team of professionals and offer services enabling further optimisation of the process of placing new medical devices on European markets.

Professionalism

MDR Regulator is built by a group of specialists with long-standing experience in legal regulations, medical technologies, lobbying, business management and marketing. We have knowledge concerning all risk classes of medical devices and borderline products, as well as experience in cooperation with notified bodies, competent authorities, accreditation bodies and the European Commission. We are well aware of the process approach to quality assurance according to ISO 13485 and ISO 9001, which is very important in the medical industry. Our activity relies on a highly qualified team, whose members – as part of sustainable development – constantly improve their qualifications, as well as openness to new solutions and development paths.