Medical Devices

With complex regulatory requirements to navigate, it’s important to partner with an Auditing Organisation you can trust.

The Medical Devices industry has recently seen an increase in the complexity of regulatory requirements, with an intended purpose to protect the end consumer.

Meet Regulatory Requirements While Protecting Consumers’ Safety

Demonstrate your commitment to product quality, operational efficiency and workplace and consumer safety.

Medical Devices Standards & Schemes

Build your competitive edge by ensuring predictable and repeatable outcomes across your people, process and technology.
Medical Device Single Audit Program (MDSAP)
The Medical Device Single Audit Program (MDSAP) is designed and developed to cover relevant requirements from the Regulatory Authorities participating in the program.
ISO 13485 Medical Devices Management Systems
Applicable to all organisations involved in the design, production, installation and servicing of medical devices and related services.
ISO 27001 Information Security Management Systems
Increased consumer expectations of information security require organisations to implement an effective ISMS framework that preserves the confidentiality, integrity and availability of information.
ISO 45001 Occupational Health and Safety Management Standard
ISO 45001 provides a robust framework for managing OHS risks and opportunities, provide a safe and healthy workplace and protect your most important asset, your people, from physical and mental health.
ISO 14001 Environmental Management Systems
ISO 14001 is an international standard prescribing a structured approach to environmental protection.

Contact Us

Speak to an expert and find out more about how SAI Global Assurance can help you on your way to business excellence.

The ABCs of MDSAP

Learn about the MDSAP requirements and how to prepare for compliance.