Quality Management

Getting your medical device to market

Building long-term success for your organization

At Qmed Consulting, the purpose of a Quality Management System is to ensure that the device will be developed, tested, manufactured and documented in accordance with general rules. The goal with the system is to keep traceability and ensure homogeneous batches and safe products. As the industry moves from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) it is important to understand the implications on the quality management system (QMS). Our team are available to support you through this transition.

How we can help
Our strategic consultants have extensive knowledge and experience in all aspects related to quality management and quality assurance. We can support you in developing and implementing a quality management system in accordance with ISO 13485 Medical devices – Quality Management Systems – Requirements for regulatory purposes, ISO 14971 Medical Devices – Application of Risk Management to medical devices, ISO 9001 Quality management systems – Requirements, GMP (Good Manufacturing practices) and applicable regulatory requirements.

Quality Management Services
Qmed Consulting can assist in:

  • Establishing a quality system according to ISO 13485 Medical devices – Quality Management Systems- Requirements for regulatory purposes.
  • MDR Gap Analysis
  • Monitoring and adjustment of your system (GAP-analysis)
  • Conducting internal or vendor audits
  • Preparing for external audits (Competent Authorities, Notified
  • Body, Customers)
  • Training in MDD and MDR and ISO 13485