This is how important QMS is for medical technology

We love processes, procedures and work instructions. If you feel differently, we have the perfect solution: our QMS service.

We are there for you when it comes to creating the foundation for your products. Our team of ISO 9001, MDSAP and ISO 13485 experts will support you along the way. Because among thousands of procedures, we know from experience exactly what is important. We get the QMS up and running for your company, team and products.

QMS in accordance with the Medical Device Regulation (MDR)

If the project to be implemented is a medical device within the meaning of the MDR, a quality management system must be developed and maintained. In most cases, the ISO 13485 is used as a basis. It is about complying with standards such as IEC 62304. These define the product development process: Software development, software maintenance, software risk management, software configuration management, software problem solving, the required technical documentation is also part of the quality management system.

This is how we support you with your QMS

  • Development of new QM systems for ISO 9001, MDSAP and ISO 13485

  • Maintaining and updating existing QMS

  • Gap analysis

  • Preparation, implementation and follow-up of certification, supplier and internal audits

  • Preparation and implementation of management review meetings

  • CAPA handling

Our certified auditors for your project

Dass wir Qualitätsmanagement-Systeme lieben, weißt Du. Dass wir zertifizierte Inhouse Auditor:innen haben, die Dein Medizinprojekt auf das nächste Level bringen, vermutlich noch nicht. Eine unserer Expert:innen hat sich dabei als IRCA Lead Auditor zertifizieren lassen.

Lass uns also gemeinsam Deine QM-Systeme nach ISO 9001, MDSAP und ISO 13485 optimieren.