MDR Regulator offers services to help medical device and in-vitro diagnostic (IVD) medical device manufacturers introduce their products into European markets, ensure the continuity and compliance of their operations with the relevant European regulations, and begin registration activities in other global markets.
We aim to comprehensively support manufacturers in bringing high-quality devices to market. Our services cover all points of the product launch process, including pre-clinical studies, clinical investigations and performance studies, device registration, and post-marketing activities.
Together with our subsidiary Pure Clinical, MDR Regulator distinguishes the uniqueness of its services to the medical device and IVD industries.
Regulatory and clinical consultancy for the medical device industry
MDR Regulator consists of a team of specialists with extensive experience in regulatory affairs, medical technology, quality management, clinical research, business management, and marketing. We monitor all regulatory changes to adapt to the dynamically changing environment. We have a rich history in cooperation with notified bodies, competent authorities, accreditation bodies, and the European Commission.
MDR Regulator focuses on transparency and honesty in customer relations, with a particular emphasis on efficiency and effectiveness. This is the result of our team’s experience in introducing medical devices to the European Union (EU) and other overseas markets.
Bespoke project management services for MedTech clients
When working with clients, MDR Regulator listens to their needs and learns how they operate. Our individual approach to each project allows us to find solutions tailored to each client’s needs. We cooperate with clients based on values such as:
- building long-term relationships based on clear and transparent rules of cooperation
- using all possible development tools
- taking on challenges
- attention to the highest quality of services
- a substantively strong team with high competence
Support for medical device development and testing
MDR Regulator offers a full range of services related to trials and performance studies of medical devices, including IVD devices, in accordance with current regulations and standards. This allows us to confirm device safety and efficacy based on reliably collected and analysed clinical data.
We cooperate with experienced clinical sites in the EU, including district, clinical and specialist hospitals, private laboratories, and university units. We know how to apply to local Independent Ethics Committees and National Competent Authorities.
Our customers can rely on us to:
- provide support at the design stage
- prepare the regulatory strategy for the project
- conduct clinical investigations and performance studies – covering the planning and designing through the main clinical investigation process, clinical site management, study termination, and summary preparation of all clinical documentation
- implement the quality management system (QMS)
- prepare the technical documentation
- oversee the certification and registration process
- provide guidance for marketing and business development activities
- implement and maintain a post-marketing surveillance system
Technical documentation for new medical devices
MDR Regulator serves as an authorised representative under SRN: PL-AR-000002485 and is responsible for regulatory compliance as an external partner, allowing us to help manufacturers comply with European regulatory requirements. Among other services, we can develop and verify device technical documentation, make technical documentation available for inspection by competent authorities, assist with device certification, and provide device registration and support for product safety activities, as well as medical incident reporting.
MDR Regulator supports medical device manufacturers in supervising complaints and other market feedback, participates in the evaluation of user information, conducts usability studies and post-market surveillance studies, offers OBL/OEM cooperation consulting services, and supports the quality management process through implementation, maintenance, and QMS verification.