IN MANY INDUSTRIES QUALITY IS REGULATED BY LAW OR INDUSTRY STANDARDS

COMPANIES ARE REQUIRED TO ENSURE THE SAFETY AND EFFECTIVENESS OF THEIR PRODUCTS

Quality matters because it is an essential component of delivering products that are reliable, safe, and effective, and that meet the needs and expectations of customers. Failing to prioritize quality can have serious consequences for businesses, including damage to their reputation, regulatory penalties, and lost sales.


FDA 21 CFR Part 820 QSR

MEDICAL DEVICE MANUFACTURERS

The QSR establishes requirements for a quality management system (QMS) that medical device manufacturers must follow in order to ensure that their products meet the necessary standards for quality and safety. The QSR also establishes requirements for the design, development, production, and distribution of medical devices, as well as requirements for record keeping and reporting.

The QSR is based on the principle that medical device manufacturers should be able to demonstrate that they are capable of consistently providing products that meet customer requirements and expectations, as well as regulatory requirements. To meet the QSR, an organization must implement a QMS that includes processes for planning, implementing, reviewing, and improving its operations

Organizations that are subject to the QSR are required to undergo regular inspections by the FDA to ensure that they are in compliance with the regulations. Non-compliance with the QSR can result in regulatory action, including warning letters, fines, and product recalls.


FDA Quality Management System Regulation

The QMSR is now in the transitiion period. In February of 2024, the FDA 21 CFR Part 820 Quality System was amended to incorporate the ISO 13485:2016. The QMSR Rule will be effective in 2026. The intention was to harmonize and modernize the FDA 21 CFR Part 820 regulation with international quality standards ISO 13485:2016. The FDA will not require ISO 13485 certification. However, companies which are ISO 13485 certified will be better able to navigate the new requirements of the QMSR.


EUROPEAN UNION MDR 745 MEDICAL DEVICE

MANUFACTURERS WHO SELL TO THE EUROPEAN UNION

The MDR Medical Device Regulation establishes requirements for a quality management system (QMS) that medical device manufacturers must follow in order to ensure that their products meet the necessary standards for quality and safety. The MDR also establishes requirements for the design, development, production, and distribution of medical devices, as well as requirements for record keeping and reporting.

The MDR is based on the principle that medical device manufacturers should be able to demonstrate that they are capable of consistently providing products that meet customer requirements and expectations, as well as regulatory requirements. To meet the MDR, an organization must implement a QMS that includes processes for planning, implementing, reviewing, and improving its operations.

Organizations that are subject to the MDR are required to undergo regular inspections by EU regulatory bodies to ensure that they are in compliance with the regulations. Non-compliance with the MDR can result in regulatory action, including warning letters, fines, and product recalls.

EUROPEAN UNION MDR 746 in vitro diagnostic medical device

MANUFACTURERS WHO SELL TO THE EUROPEAN UNION

In vitro diagnostic medical devices are products that are used to examine samples of substances taken from the human body, such as blood or tissue, in order to diagnose or monitor diseases or other medical conditions. Examples of IVD medical devices include diagnostic test kits, imaging devices, and medical laboratory equipment.

The IVDR establishes requirements for a quality management system (QMS) that manufacturers of IVD medical devices must follow in order to ensure that their products meet the necessary standards for quality and safety. The IVDR also establishes requirements for the design, development, production, and distribution of IVD medical devices, as well as requirements for record keeping and reporting.

The IVDR is based on the principle that manufacturers of IVD medical devices should be able to demonstrate that they are capable of consistently providing products that meet customer requirements and expectations, as well as regulatory requirements. To meet the IVDR, an organization must implement a QMS that includes processes for planning, implementing, reviewing, and improving its operations.

Organizations that are subject to the IVDR are required to undergo regular inspections by EU regulatory bodies to ensure that they are in compliance with the regulations. Non-compliance with the IVDR can result in regulatory action, including warning letters, fines, and product recalls.