Elevating Quality Management for Your Medical Device’s Market Entry

Fostering Long-term Success for Your Organization

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:

  • Establishing a robust quality system in accordance with ISO 13485 Medical devices – Quality Management Systems – Requirements for regulatory purposes.
  • Conducting MDR Gap Analyses to align with the new regulatory landscape.
  • Continuously monitoring and fine-tuning your system through GAP analyses.
  • PMS activities including plan and report
  • Performing internal or vendor audits to ensure compliance and efficiency.
  • Preparing diligently for external audits by Competent Authorities, Notified Bodies, or Customers.
  • Offering training programs tailored to MDD, MDR, ISO 13485, and more, empowering your team with the latest knowledge and skills.

Choose Qmed Consulting to bolster your Quality Management efforts and ensure your medical device’s success in the market.