Medical devices are crucial for healthcare industries as it depends largely on these devices for diagnosis, surgical procedures, and ultimately, patient care. These devices must work efficiently, as expected to ensure quality in healthcare services. This is why medical industry always picks devices that are quality assured.
ISO (International Organization for Standardization) publishes international technical standards. In the medical device field, ISO certifications help ensure safety, quality, and regulatory compliance throughout the lifecycle of medical devices, which is inclusive of design, manufacture, distribution, servicing etc.
One of the central standards is ISO 13485 or quality management system for medical device manufacturing. This standard specifies requirements for a quality management system for medical device producers and related stakeholders.
In the Kingdom of Saudi Arabia (KSA) other Other ISO / IEC (or equivalent) standards relevant to medical devices also exist. These are for risk management (e.g. ISO 14971), user-interface/usability, software, sterilization, packaging, etc.Manufacturers can check their industrial requirements to determine their need for ISO certification.
Variations &types of certifications in Saudi Arabia
Saudi Arabia, through its regulatory authority (the Saudi Food & Drug Authority, SFDA), imposes certain requirements for medical devices to ensure safety, quality, and patient protection. There are standards likeISO 13485 for medical device manufacturing, as well as others in risk management. In fact, there are many ISO certifications available to help companies regulate their operations and be able to deliver quality products.
Achieving ISO certification (especially ISO 13485) for medical devices in Saudi Arabia involves understanding both international standards and local SFDA-regulations, performing a gap analysis, building and documenting a compliant Quality Management System, selecting an approved certifier, passing audits, and maintaining the system.
For any assistance, contact ISO experts at Infomatics Consultancy Co. Get the required consultation for the most appropriate quality standard to follow and remain compliant while delivering quality medical devices to the healthcare industry within KSA and other countries.