Quality Management Systems: ISO 13485

At MDS Finland, we specialize in setting up and customizing Quality Management Systems (QMS) compliant with ISO 13485:2016, a crucial standard for medical device manufacturing companies. Our approach ensures that your QMS meets the specific requirements of your role in the industry—whether you are a manufacturer, distributor, or importer—and addresses the unique characteristics of your products, be they software, sterile, or electronic devices.

Our Quality Management System Services Include:

Prefilled Document Templates

We provide prefilled document templates for ISO 13485:2016, making the implementation process more efficient.

Customization of QMS

Our team customizes your Quality Management System to fit your specific requirements, ensuring compliance with both ISO 13485 and applicable MDR standards.

Comprehensive Documentation Package

We present a complete documentation package, including Standard Operating Procedures (SOPs) and usage guidelines.

Documentation Editing

We edit and align your existing processes with the ISO 13485 standard and MDR requirements, ensuring seamless integration.

Staff Training

We train your personnel on the QMS and associated documentation, ensuring complete understanding and effective implementation.

QMS Maintenance Planning

We assist in planning a yearly schedule for QMS tasks, essential for its maintenance and ongoing compliance.

Audit and Certification Support

Our services extend to assisting in the selection of certification bodies, with active participation in pre-audit and certification audit processes.

WHY CHOOSE ISO 13485 CERTIFICATION?

Obtaining ISO 13485 certification is pivotal for medical device manufacturers, designers, and distributors. It demonstrates compliance with stringent regulatory requirements, ensures patient safety, and enhances marketability. With our certification support, you can gain confidence in your QMS and maintain compliance effectively. In addition, aligning your quality management system with ISO 13485 helps meet other global regulatory expectations—such as the FDA’s Quality System Regulation (QSR)—broadening your access to international markets.