Omnex Medical Devices Quality Management System Services

ISO 13485 serves as the global standard outlining the requirements for a quality management system (QMS) that showcases an organisation’s capability to consistently deliver medical devices and associated services meeting both customer and regulatory demands in the field. The International Organization for Standardization (ISO), based in Geneva, Switzerland, is an independent, non-governmental entity responsible for developing voluntary International Standards. The stipulations of ISO 13485 are tailored to organisations involved in the provision of medical devices, regardless of their size or type, and are applicable to any entity engaged in any stage of a medical device’s life cycle.

The key aim of ISO 13485 is to streamline regulatory requirements for QMSs in the medical device sector. Adherence to ISO 13485 is often considered the initial step towards regulatory compliance. The latest version of the standard, released in 2016, aims to offer a QMS standard that is easily comprehensible and designed specifically for regulatory purposes. Both the FDA and European regulatory bodies endorse ISO 13485. Omnex specialises in integrating FDA 21 CFR 820 requirements and European Union Medical Device regulations into ISO 13485 QMS implementations. The company has also successfully incorporated Japanese and Canadian regulatory standards into management systems. Organisations seeking to align with multiple regulatory frameworks and comply with regulations from the US, Canada, Brazil, Japan, and Australia can explore the Medical Device Single Audit Program (MDSAP).

Gain insights from Omnex’s QMS experts on how to establish and/or assess ISO 13485 systems, including risk management methodologies using Best In Class approaches. Attend webinars on ISO 13485 and MDSAP.

The Medical Device Single Audit Program (MDSAP) was created by a consortium of medical device regulators to enable accredited third-party auditors to conduct a single audit covering both ISO 13485:2016 and relevant regulatory requirements.

The International Medical Device Regulators Forum (IMDRF) acknowledges that a unified approach to auditing and monitoring medical device manufacturing could enhance safety and oversight on a global scale.

The FDA, alongside Australia’s Therapeutic Goods Administration, 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 partake in an MDSAP Pilot. The FDA will accept MDSAP audit reports as a substitute for routine Agency inspections. The MDSAP audit will fulfil the relevant requirements of participating medical device regulatory authorities in the pilot program.

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