OUR QUALITY MANAGER SERVICES INCLUDE
Strategic Regulatory Compliance
Developing strategies for regulatory compliance, including conformity assessment and change management procedures for devices.
Ensuring compliance with the general safety and performance requirements (GSPRs) as per the EU MDR.
Quality Management System Oversight
Developing strategies for regulatory compliance, including conformity assessment and change management procedures for devices.
Ensuring compliance with the general safety and performance requirements (GSPRs) as per the EU MDR.
Risk Management
Implementing risk management methodologies as outlined in the EU MDR, focusing on the safety and performance of medical devices throughout their lifecycle.
Clinical Evaluation and Post-Market Activities
Overseeing the clinical evaluation process and post-market surveillance (PMS) activities.
Managing post-market clinical follow-up (PMCF) as required by the EU MDR.
Audit Management
Planning and executing internal audits, and managing external audits.
Liaising with notified bodies and other certification bodies for audit-related activities.
Documentation Management
Updating and maintaining critical QMS documentation, such as the quality manual, process, and work instructions.
Ensuring the technical file documentation is current and comprehensive.
Incident Management and Reporting
Investigating serious incidents and near-misses, and ensuring timely reporting to relevant authorities.
Managing communications with national competent authorities.
Post-Market Surveillance (PMS) and Clinical Evaluation Reports (CER)
Overseeing PMS processes and regularly updating Clinical Evaluation Reports.
Customizable Service Delivery
Tailoring our Quality Manager responsibilities and activities to align with the agreed-upon responsibility matrix with your company.
WHY CHOOSE MDS FINLAND FOR QUALITY MANAGER SERVICES?
Expertise in EU MDR Compliance
Our Quality Managers are well-versed in the EU MDR requirements, ensuring your organization’s compliance with the latest regulations.
Holistic Quality Management
We offer a holistic approach to quality management, participating in regular quality checks and weekly operations with various stakeholders.
Tailored Solutions
Our services are flexible and can be fully outsourced according to your needs, following an annual calendar for systematic quality management.
Comprehensive Support
From timely audits to notifications and documentation in potential error situations, we ensure all aspects of quality management are meticulously handled.
ENSURING QUALITY AND COMPLIANCE
MDS Finland is committed to supporting your organization in achieving and maintaining the highest standards of quality and regulatory compliance. Our Quality Manager service ensures that your medical devices meet the stringent requirements of the EU MDR, fostering product excellence and patient safety.
