ISO 13485 – types and uses

The International Organisation for Standardization (ISO) established the ISO 13485 standard to specify regulatory requirements for medical device manufacturers’ quality processes. It gives the manufacturers a fundamental outline to follow so that they might better meet customer needs and industry compliance requirements. More and more medical devices rely solely on advanced software. It’s crucial, now more than ever, that not only the devices themselves comply to the ISO 13485, but the software must do so too. Inadequate verification and faulty system could lead to unexpected device failures and patient harm. This cannot be accepted. Thus, new ISO 13485 requirements that are frequently updated do not only review the devices, but also its software.

Quality management software

Used to help automate any regulated process in the design, manufacture and distribution of medical devices, quality management software is one of the most important and most frequently used ones on the market of medical devices. Each step of the way, there are regulations put on the manufacturer by ISO 13485. Meeting those standards and providing the best quality, high end devices is a goal for everyone in the industry. Making sure that all the devices are safe to work in hospitals, clinics and any medical facilities and won’t cause harm to patients is crucial. Any malfunctions and faults that may occur on the production line are quickly found by the quality management software and such devices are stopped from being developed any further. Without the specialist software, those malfunctions could possibly be omitted and dangerous if not found on time.

MRI device

Documentation management software

Compliance to ISO 13485 is necessary if you want your medical devices to hit the market. However, even if your products are meeting all the requested standards, you still need official validation on all of them. Documentation management software is here to make sure that all your electronic signatures are made on time and that every step of your production process is properly validated. Such software helps you automate your management system and makes your organisation more efficient and productive.

ISO 13485 requires producers of medical devices to establish satisfactory quality systems and to implement quality procedures that are properly documented, controlled and maintained. Automated ISO 13485 software can help device organisations achieve their regulatory and business goals and maintain an efficient work process without having to check every requirement manually. For further read please visit