Quality Manager Service at MDS Finland

MDS Finland specializes in providing comprehensive Quality Manager services tailored to the unique needs of your organization in the medical device sector. Our approach is aligned with the rigorous standards set by the EU Medical Device Regulation (MDR) and focuses on maintaining and enhancing the quality management systems and technical files critical for regulatory compliance and product excellence.

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

Managing and maintaining the Quality Management System (QMS) to ensure it meets the EU MDR standards.

Implementing continuous improvements to the QMS, ensuring it remains effective and up-to-date.

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.