Trainings Medical Devices

ISO 13485 is the international standard that specifies the requirements for a quality management system (QMS) designed to demonstrate an organization’s ability to consistently provide medical devices and associated services that meet both customer expectations and regulatory requirements in the field. Developed by the International Organization for Standardization (ISO), headquartered in Geneva, Switzerland, this independent, non-governmental organization is responsible for establishing voluntary International Standards. The requirements outlined in ISO 13485 are tailored for organizations involved in the manufacturing and provision of medical devices, applicable to entities of any size and at any stage of a medical device’s life cycle.

The primary goal of ISO 13485 is to simplify regulatory compliance for QMSs within the medical device sector. Compliance with ISO 13485 is often viewed as the first step toward achieving regulatory adherence. The most recent version of the standard, released in 2016, is designed to provide a clear and straightforward QMS framework with a focus on regulatory purposes. Both the FDA and European regulatory authorities endorse ISO 13485. Omnex specializes in integrating FDA 21 CFR 820 requirements and European Union Medical Device regulations into ISO 13485 QMS implementations, and has also successfully incorporated Japanese and Canadian regulatory standards into management systems. Organizations aiming to comply with various regulatory frameworks in the United States, Canada, Brazil, Japan, and Australia may consider the Medical Device Single Audit Program (MDSAP).

Leverage the expertise of Omnex’s QMS specialists to learn how to establish or assess ISO 13485 systems, including implementing risk management methodologies based on Best-in-Class approaches. Join our webinars on ISO 13485 and MDSAP. The Medical Device Single Audit Program (MDSAP) was established by a consortium of medical device regulators to allow accredited third-party auditors to perform a single audit that fulfills both ISO 13485:2016 standards and relevant regulatory requirements.