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Quality Management for Medical Devices

It’s no easy task to establish processes, competencies, roles, and document structures in a medical technology business that are both regulatory-compliant and ensure efficiency and competitiveness. With many years of industry experience and countless successful projects behind us, we can help you sharpen your operations.

  • ISO 13485
  • ISO 9001
  • FDA QMSR
  • EN 62304
  • IEC 62366
  • ISO 14971
  • ISO 27001
  • IEC 81001-5-1
  • ISO 10993
  • etc...
Quality Management for Medical Devices

Certification with Medos

A quality system certification is often a key milestone on the path to market. We are happy to assist you in setting up a project to achieve certification for ISO 13485 or MDSAP. Our consultants are trained lead auditors with many years of experience conducting external audits, internal audits, and supplier audits.

The Value of a Workshop

When we develop or enhance a quality management system, we typically work in a workshop format. This means our consultants prepare an engaging session that often includes both training and collaborative visual process modeling. Of course, we also provide turnkey documents and solutions where appropriate—allowing us to focus together on what truly drives the development of your business.

Success Factors

Training, coaching, and support are some of the key success factors for effective quality management. Read our article on the most important factors when implementing a QMS in a small business.

Key Success Factors for Small Business Quality Management Systems

Focalcube eQMS, e-QMS

Focalcube eQMS

Focalcube.com is our own eQMS, developed by Medos here in Sweden. Focalcube offers the most user-friendly cloud solution for quality management on the market. It brings together everything needed for successful quality management. Focalcube is designed to meet standards for quality management systems such as ISO 13485, ISO 14001, and ISO 9001. It’s easy for employees to get started and begin using the system. Focalcube can be used to manage various tasks, change orders, internal and external audits, documents, digital signatures, and much more.

Check out Focalcube today!