ISO 13485 Medical Devices

About ISO 13485 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.