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.
Quality Management Services
Qmed Consulting can assist in:
- Establishing a quality system according to the rules for medical devices, containing required procedures, instructions and forms
- MDR Gap Analysis
- Monitoring and adjustment of your system (GAP-analysis)
- Conducting internal or vendor audits
- Preparing for external audits
- Training in MDD and MDR and ISO 13485
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, ISO 14971, ISO 9001, GMP and applicable regulatory requirements.
Contact us and learn more about our Quality Management offerings.