Expertise.
MDR Consulting.
Meet the requirements of the Medical Device Regulation (MDR) and bring your medical devices safely to market.
Competent?
Are your products already MDR-compliant and prepared for the new requirements?
Are you sure?
Do your processes ensure full compliance with the MDR requirements?
Efficient?
Is your approval process optimized to avoid delays?
Ensure your MDR compliance and market authorization.
MDR Consulting - MDR compliance and market authorization .
Our MDR Consulting Services offer you comprehensive support in meeting the MDR requirements and obtaining safe market approval for your medical devices.
The Medical Device Regulation (MDR) places stricter requirements on medical devices, and our experts can help you to meet these requirements efficiently. We review your existing processes, identify potential compliance gaps and offer comprehensive solutions from the creation of technical documentation to communication with notified bodies.
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 post-market surveillance plans and monitoring of product safety.
MDR Consulting Services at a glance.
Our MDR Consulting Services help you to fully comply with the MDR requirements and bring your products safely to market.
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 products in the EUDAMED database
Post-market surveillance (PMS) and vigilance.
- Development of post-market surveillance plans
- Systematic monitoring of product safety after market launch
- Support with incident reporting
Successful MDR Consulting projects.
Our MDR consulting projects help companies to efficiently approve their medical devices in accordance with the MDR requirements and to remain MDR-compliant in the long term.
MDR compliance for a medical technology company
MDR compliance and risk management for a pharmaceutical company
MDR approval process for a diagnostics company
Challenge.
A diagnostics company had to prepare its products for MDR approval, including clinical performance evaluation and risk assessment.
Measures.
- Implementation of the clinical performance evaluation according to MDR
- Preparation of technical documentation and submission to the notified bodies
- Support for post-market surveillance and vigilance
Results.
- Full MDR approval of 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.
Our Regulatory Affairs Consulting Portfolio.
Our Regulatory Affairs Consulting portfolio offers comprehensive solutions to optimize your market access and ensure regulatory compliance.
We support you in fulfilling the MDR requirements, from the creation of documentation to the implementation of safety and performance requirements.
- General safety and performance requirements (Annex I): We help you to comply with the more than 23 requirements of the MDR, including risk management and risk-benefit assessment
- Risk management (ISO 14971): Implementation of a risk management system that covers the entire product life cycle and takes into account all relevant MDR requirements
Creation and maintenance of technical documentation, management of the Unique Device Identification (UDI), and registration of your products in the EUDAMED database.
- Technical documentation (Annex II): We ensure that your technical documentation is complete and up to date in order to comply with the MDR requirements and approve your products safely
- UDI and EUDAMED: Implementation of the UDI system and registration of your products in the EUDAMED database to ensure traceability
Development of post-market surveillance plans, systematic monitoring of product safety and support in reporting incidents.
- Post-Market Surveillance System (Annex VII): Establishment of a robust post-market surveillance system for the continuous assessment of product safety
- Periodic Safety Update Reports (PSUR): Regular generation of safety reports to ensure the performance and safety of your products
