Medical Industry Solutions

ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. ISO is the International Organization for Standardization, an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards, headquartered in Geneva, Switzerland. Requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size, and can be used by any organization involved in one or more stage(s) of the life-cycle of a medical device.

The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for QMSs. Compliance with ISO 13485 is often recognized as the first step in achieving compliance with regulatory requirements. The 2016 version of the standard has as its goal that it "provides an easily understood Quality Management System (QMS) standard that is designed for REGULATORY purposes." The ISO 13485 is embraced both by the FDA and the European regulatory bodies. Omnex specializes in implementations where the FDA 21 CFR 820 regulatory requirements and the European Union Medical Device regulation are integrated into the ISO 13485 QMS. We have also implemented management systems that included Japanese and Canadian regulatory requirements. Organizations that want to integrate multiple regulatory requirements and achieve compliance with the US, Canadian, Brazilian, Japan, and Australian regulations can look at MDSAP. 

Learn from Omnex's QMS experts on how to implement and/or audit ISO 13485 systems including risk management methodology with Best In Class methods. See Webinars on ISO 13485 and MDSAP.

The Medical Device Single Audit Program (MDSAP) was developed by a group of medical device regulators to allow recognized third-party auditors to conduct a single audit of a medical device manufacturer that will cover ISO 13485:2016 and their respective regulatory requirements.

The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.

The FDA along with the Therapeutic Goods Administration of Australia, Brazil's Agencia Nacional de Vigilancia Sanitaria, Health Canada, Japan's Ministry of Health, Labour and Welfare, the Japanese Pharmaceuticals and Medical Devices Agency, the World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) will be participating in an MDSAP Pilot. The FDA will accept the MDSAP audit reports as a substitute for routine Agency inspections. MDSAP audit will satisfy the relevant requirements of the medical device regulatory authorities participating in the pilot program.

Omnex specializes in implementing MDSAP programs that integrate ISO 13485 along with multiple regulatory requirements of agencies worldwide. Contact Us for more information on how Omnex can help your organization.