Quality Management Systems

Design, implementation, and optimization of Medical Device QMS for software-driven and hybrid MedTech organizations.

Quality Management Systems

Services

  • QMS design, implementation, and continuous improvement

  • Design controls and software validation

  • Risk management and patient safety processes

  • SOP authoring, document control, and change management

  • CAPA, complaints handling, and post-market surveillance

  • Supplier quality management and QMS digitization

Relevant Standards and Regulations

  • ISO 13485 – Medical Devices Quality Management Systems

  • ISO 9001 – Quality Management Systems

  • IEC 62304 – Medical Device Software Lifecycle Processes

  • ISO 14971 – Risk Management for Medical Devices

  • ISO 62366-1 – Usability Engineering

  • FDA 21 CFR Part 820 (QSR)

  • EU MDR (2017/745) & IVDR (2017/746)