Comprehensive EU MDR 2017/745 Support

Welcome to Safetek’s EU MDR 2017/745 Support! We ensure compliance for medical device manufacturers, covering certification, MDSAP consultancy, and testing.

Regulatory Assessment

Our experienced consultants conduct a thorough assessment of your medical devices to determine their classification under the EU MDR. We review your product portfolio, labeling, and technical documentation to identify any gaps or areas that require attention to meet the new regulations. Our experts provide guidance on the regulatory pathway for each device and assist you in developing a comprehensive compliance strategy.

Gap Analysis and Remediation

To ensure compliance with the EU MDR, it is crucial to identify and address any gaps in your current processes and documentation. Our consultancy organization performs a detailed gap analysis, comparing your existing quality management system and technical documentation against the requirements of the EU MDR. We provide a comprehensive report outlining the identified gaps and offer remediation strategies to bring your devices and processes in line with the new regulations.

Technical Documentation Update

Under the EU MDR, the technical documentation requirements have become more stringent. Our consultants assist you in updating your technical documentation, including design documentation, risk management files, clinical evaluation reports, and post-market surveillance plans. We ensure that your documentation meets the requirements of the EU MDR and reflects the latest scientific and regulatory standards.

Notified Body Interaction

Navigating the new regulatory landscape of the EU MDR requires effective communication with Notified Bodies. Our consultancy organization provides support in preparing for and managing interactions with Notified Bodies. We assist in selecting a suitable Notified Body, preparing for audits, addressing any queries or findings, and ensuring a smooth certification process.

Post-Market Surveillance

The EU MDR places significant emphasis on post-market surveillance activities. Our experts guide you in establishing robust post-market surveillance systems and processes, including complaint handling, vigilance reporting, and periodic safety update reporting. We help you develop a proactive approach to monitoring the safety and performance of your medical devices in the market.

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