• Medical Device Labeling Compliance Under the EU MDR 2017/745
    August 18, 2022 Medical Devices

    Labeling is an integral part of marketing medical devices. The label is a piece of information affixed with the device and/or packaging in a human-readable format. The main purpose of labeling is to provide safety information to users who can be healthcare professionals, consumers, or any other relevant person.

  • The FDA 21 CFR PART 820: Medical Devices Quality System Regulation (QSR)
    May 6, 2021 Medical Devices

    Determining and setting up a quality system is a challenging task for medical devices manufacturers. A robust quality system covers the aspects like the medical device design, manufacturing, supplier management, product labeling, storage & distribution, clinical data, risk management and complaint handling.

  • medical-devices-qms-key-elements-of-iso-13485-standard
    March 30, 2021 Medical Devices

    Maintaining a Quality Management System (QMS) is the foundation to demonstrate Regulatory compliance in the medical devices industry. QMS is a structured system of procedures and processes, covering all the aspects of design, manufacturing, risk management, supplier management, complaint handling, clinical data, storage, distribution and product labeling of medical devices.

  • Medical Device Compliance and Quality Management System (QMS)
    December 21, 2020 Medical Devices

    Building and managing an efficient Quality Management System (QMS) is a crucial step for medical device enterprises willing to deliver the right product to the customers. As almost all major markets across the globe made it a thumb rule to go by a compliant QMS while registering the products, it is indeed a primary requirement for manufacturers to maintain QMS for a successful product launch...