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:
In vitro diagnostic medical devices
Why choose MDR Regulator?
We meet all the requirements 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.
EU Authorised Representative
We offer representation for manufacturers from outside the European Union who want to place their product on European markets. The representation services include:
- registering the product in the European Union and ensuring compliance with standards,
- reviewing technical documentation and ensuring its validity,
- identifying EU standards and national requirements,
- participating in the field safety corrective actions (FSCA) process
Person Responsible for Regulatory Compliance in accordance with MDR
We offer outsourcing of the function of the person responsible for regulatory compliance to meet the requirements of the new MDR. We have the necessary competence in the field of medical devices, as detailed in the regulation. The scope of the outsourcing includes:
- checking conformity of medical devices with the MDR and Quality Management System requirements,
- ensuring all technical documentation is drawn up and up to date,
- contributing to the mandatory post-market surveillance,
- product registration.
MDR Regulator not only helps to place the product on the European market but also ensures that the Manufacturer’s post-market surveillance obligations are met
We offer full support in the following areas:
- updates on international legal regulations,
- product classification/qualification,
- identification and registration of borderline products,
- obtaining free sale certificates,
- obtaining free sale certificates,
- looking for new importers/distributors on EU markets,
- Manufacturer’s insurance,
- verification of legal requirements and registration of food supplements,
We will be happy to provide support in other areas, too. Please contact us to discuss details
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.
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.