Expertise.
MDR Consulting.
Competent?
Secure?
Efficient?
Ensure your MDR compliance and market authorization.
MDR compliance and market approval of your medical devices.
Our services include:
- Regulatory compliance: Ensuring that your products fully comply with the MDR regulations.
- Technical documentation: Creation and maintenance of technical documentation and support with UDI implementation.
- Post-market surveillance: development of plans and monitoring of product safety.
MDR Consulting Services at a glance.
Regulatory compliance.
- Support in the creation and management of technical documentation.
- Compliance with MDR safety and performance requirements.
- Comprehensive regulatory advice.
Technical documentation and UDI.
- Preparation of technical documentation in accordance with MDR.
- Management of the Unique Device Identification (UDI).
- Registration of the products in the EUDAMED database.
Post-market surveillance and vigilance.
- Development of post-market surveillance plans.
- Systematic monitoring of product safety after market launch.
- Support in the reporting of incidents.
Successful MDR Consulting projects.
Challenge.
A diagnostics company had to prepare its products for MDR approval, including clinical performance evaluation and risk assessment.
Measures.
- Performance of the clinical performance evaluation according to MDR.
- Preparation of the technical documentation and submission to the notified bodies.
- Support for post-market surveillance and vigilance.
Results.
- Full MDR approval of the diagnostic products.
- Ensuring product safety after market launch.
- Efficient monitoring and risk minimization.
Success.
The company was able to successfully launch its products on the market and ensure MDR compliance in the long term.
Ensure the MDR compliance of your products for the European market.
Our MDR Consulting Service Portfolio.
We support you in fulfilling the MDR requirements, from the creation of technical documentation to the implementation of safety and performance requirements. Our expertise helps you to meet the risk management requirements of ISO 14971 and to optimize the risk-benefit ratio of your products. Further information on the MDR can be found on the official website of the European Commission.
While the MDR defines the regulatory requirements in Europe, we also support you in complying with global standards. Our international MDR experts will accompany you as you enter new markets and ensure that your products comply with regulatory requirements worldwide, including FDA or MDSAP requirements.
Find out more about our services under Global Market Access.
