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At Qmed Consulting, the primary objective of a Quality Management System (QMS) is to ensure that your device undergoes development, testing, manufacturing, and documentation in strict accordance with established standards. The overarching aim of this system is to uphold traceability, ensure consistency across batches, and guarantee the production of safe and reliable products. In light of the industry’s transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), it is crucial to grasp the implications for your Quality Management System (QMS). Our proficient team stands ready to guide you through this pivotal transition.
How We Can Be of Service
Our strategic consultants possess extensive knowledge and experience encompassing all facets of quality management and quality assurance. We offer comprehensive support in the creation and implementation of a Quality Management System aligned 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, Good Manufacturing Practices (GMP), and applicable regulatory standards.
Qmed Consulting can aid you in:
Choose Qmed Consulting to bolster your Quality Management efforts and ensure your medical device’s success in the market.
Koebmagergade 53, 1.
DK-1150 Copenhagen K.
Denmark
+45 56 64 10 10
info@qmed-consulting.com
Proud sponsors of
Red Cross and Mothers Aid.
Qmed Consulting is an ISO 9001:2015
& 14155:2020 certified company.
