ISO 13485 is a regulatory requirement specifically applicable to medical device manufacturers. It is based on ISO 9001:2015 and is applicable to companies of any size. The standard focuses on risk management and requires the documentation of all interrelated processes, including forms and templates. It requires manufacturers to have a quality management system (QMS) in place to facilitate continuous improvement of its operations and ensure sustainable development. A formal QMS assures customers that the product will deliver on its promise and meet their quality requirements.
ISO 13485 compliance also helps with conformity assessment options used in various regulatory jurisdictions. It enables effecting improvements based on feedback received in the form of complaints, post-market surveillance reports, managing nonconformities, and taking corrective actions and preventive actions. The standard helps ensure that the QMS is cost- and time effectively facilitating improvements.
ISO 13485 compliance is essential for medical devices across all countries who have incorporated the standard as part of their regulations or as a consistent standard for quality programs. Auditing the QMS system of an enterprise by an independent certifying body or registrar is a must for demonstrating compliance with the ISO 13485 standard.
A compliant manufacturing process enables the medical device manufacturer to make the device safer and more effective. This will improve customer satisfaction by meeting or exceeding their expectations. A well-implemented ISO 13485 system will also enhance the efficiency of the supply chain, improve risk management and design controls, and reduce the number of audits needed before entering any major global market.
In this whitepaper, we talk about:
- End-to-end management of medical device lifecycle
- ISO 13485:2016 quality management practices
- The key ISO 13485 requirements for medical device manufacturing
- Automation of key ISO 13485 processes
- And more