Accreditation for Medical Device Quality Management Systems

Accreditation for medical device quality management systems refers to the process of evaluating and certifying that an organization has a management system in place to ensure the quality and safety of the medical devices it produces, processes, or sells. Medical device quality management systems are designed to help organizations identify and manage quality and safety risks, and to ensure that they produce, process, or sell medical devices in a safe and effective manner.

To obtain accreditation for a medical device quality management system, an organization must typically demonstrate that it has the necessary policies, processes, and procedures in place to manage the quality and safety of its medical devices effectively. This may include demonstrating that the organization has appropriate staffing levels, that it follows established best practices and guidelines, and that it has systems in place to monitor and improve the quality and safety of its medical devices.

There are several different accreditation standards that may be applicable to medical device quality management systems, depending on the specific type of organization and the industry in which it operates. For example, the International Organization for Standardization (ISO) has developed a standard for medical device quality management, ISO 13485, which provides guidance on the principles and processes for managing the quality and safety of medical devices effectively.

Obtaining accreditation for a medical device quality management system can be beneficial for several reasons. It can help to demonstrate the organization's competence and credibility to regulatory bodies, customers, and other stakeholders, and may be required in order to qualify for certain contracts or business opportunities. Accreditation can also help to improve the quality and safety of the medical devices being produced, processed, or sold, and may lead to increased customer satisfaction and trust in the organization's brand.

ISO 13485 specifies requirements for a quality management system for the design and development, production, installation, and servicing of medical devices, and the design, development, and provision of related services. It can also be used to assess the organization's ability to meet customer and regulatory requirements.

ISO 13485 stipulates requirements for a quality management system for the design and development, manufacturing and servicing of medical devices. The quality management system requirements specified in ISO 13485 are complementary to technical requirements for products.

It can also be used to assess the organization's ability to meet customer and regulatory requirements. A Certification body applying for ISO 13485 accreditation must conform to ISO/IEC 17021, MD9 and other additional International requirements as detailed in Specific Requirements for Accreditation for Medical devices - Quality management systems Scheme.

Medical Devices Quality Management Systems are an specific standard for medical device industry which fulfils specific needs related to production of a particular medical device such as production control, quality management & regulatory compliances. The objective of MDQMS i.e. ISO 13485:2016 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems.

Certification Bodies interested to apply for an Accreditation scheme for Medical Devices Quality Management Systems can send an email at [email protected]