Our Outsourced Quality Manager Services Include
Strategic Regulatory Compliance
Developing strategies for regulatory compliance, including selecting appropriate conformity assessment procedures and managing change control for your devices.
Quality Management System Oversight
Managing and maintaining your QMS to ensure it meets EU MDR standards. We implement continuous improvements to keep the QMS effective and up-to-date.
Risk Management
Applying risk management methodologies as outlined in the EU MDR, focusing on the safety and performance of your medical devices throughout their lifecycle.
Clinical Evaluation and Post-Market Activities
Overseeing the clinical evaluation process and post-market surveillance (PMS) activities, including managing Post-Market Clinical Follow-up (PMCF) as required by the MDR.
Audit Management
Planning and executing internal audits and facilitating external audits. We liaise with Notified Bodies and other certification bodies for all audit-related activities.
Documentation Management
Updating and maintaining all critical QMS documentation (e.g., quality manuals, processes, work instructions) and ensuring technical file documentation is current and comprehensive.
Incident Management and Reporting
Investigating serious incidents and near-misses and ensuring timely reporting to relevant authorities. We also manage communications with national competent authorities when required.
Post-Market Surveillance (PMS) and Clinical Evaluation Reports (CER)
Overseeing ongoing PMS processes and regularly updating Clinical Evaluation Reports (CER) to reflect the latest clinical data and field experience.
Why Choose MDS Finland for Outsourced Quality Manager Services
Expertise in EU MDR Compliance
Our Quality Managers are well-versed in EU MDR requirements, ensuring your organization remains compliant with the latest regulations.
Holistic Quality Management
We take a comprehensive approach to quality management, participating in regular quality checks and integrating with your team’s routine operations.
Tailored Solutions
Our service is flexible and can be fully outsourced or adjusted to your needs. We work with you to define a responsibility matrix and follow an annual quality calendar for systematic management.
Comprehensive Support
From conducting timely audits to handling documentation and notifications in potential issue situations, we ensure that all aspects of quality and regulatory compliance are meticulously managed.
ENSURING QUALITY AND COMPLIANCE
MDS Finland is committed to helping your organization achieve and maintain the highest standards of quality and regulatory compliance. Our Outsourced Quality Manager service ensures that your medical devices meet the stringent requirements of the EU MDR, fostering product excellence and patient safety.
