ISO 13485:2016 is the international standard for Medical Devices Quality Management Systems. ISO 13485 specifies the requirements for a Quality Management System (QMS) for organisations that are focused on one or some of the processes in design, production, installation, and servicing of medical devices and related services. ISO 13485 helps ensure that organisations consistently meet regulatory and customer requirements for safe and effective medical devices.
Compliance with ISO 13485 is very important for organisations involved in medical device manufacturing, supply of components to manufacturers of medical devices, distribution or importation of medical devices, healthcare organisations, and laboratories using medical devices including bespoke devices.
Devices are classified by organisations such as the International Medical Device Regulators Forum (IMDRF), EU Medical Device Regulation (MDR), World Health Organisation (WHO), and the USA Food and Drug Administration (FDA).
The FDA classification is as follows:
Class I - Low Risk - General Controls (Registration, Labeling, GMP) - Example Products include bandages, examination gloves, and tongue depressors.
Class II - Moderate Risk - General & Special Controls (Performance testing, Labelling) - Example products include blood pressure monitors, syringes, and contact lenses.
Class III - High Risk - Controls include Premarket Approval (PMA), Clinical Trials - Example products include pacemakers, implantable defibrillators, and heart valves.
Implementing and obtaining certification to ISO 13485 Medical Devices enhances product quality and patient safety, facilitates market access and product sales by meeting global regulatory requirements, strengthens an organisations risk management and compliance practices, improves operational efficiency and process standardisation, and increases customer confidence and business credibility.
CertCrowd provides a simple, practical and affordable approach to the implementation and compliance with ISO 13485 Medical Devices. Whether your organisation needs a system, assistance to implement all or parts of the framework, or need to get audited or certified; CertCrowd has the solutions for you.
Get an ISO 13485 Medical Devices system in place with CertCrowd in super fast, follow our Start-Up Guide or engage with our consultants for a guaranteed compliance process, you'll be ready for your audit and certification before you know it.
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Implement your ISO 13485 Medical Devices system with minimum hassles with CertCrowd. CertCrowd comes with all the policies and procedures, actions, assessments, internal audits, risk assessments, incident management and reports you need, follow our Start-Up Guide or get us to help you customise your system to your specific needs and processes.
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