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 companies. Our approach ensures that your QMS meets the specific requirements of your role in the industry, whether as a manufacturer, distributor, or importer, and caters to the nature of your products, be it software, sterile, or electronic devices.

OUR SERVICES INCLUDE

Prefilled Document Templates

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

Customization of QMS

Our team customizes the QMS to fit your specific requirements, ensuring compliance with both ISO 13485 and MDR requirements.

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 or responsible individuals on the QMS and documentation, ensuring complete understanding and implementation.

QMS Maintenance Planning

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

Audit and Certification Support

Our services extend to assisting in the selection of certification bodies, and we actively participate in pre-audit and certification audit processes.

WHY CHOOSE ISO 13485 CERTIFICATION?

ISO 13485 certification is pivotal for medical device manufacturers, designers, and distributors. It demonstrates compliance with regulatory requirements, ensures patient safety, and enhances marketability. Our certification support helps you gain confidence in your QMS and maintain compliance effectively.