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MDSAP Audit Approach (MDSAP AU P0002)

What is MDSAP Audit Approach (MDSAP AU P0002)?

The MDSAP Audit Approach (MDSAP AU P0002.011) as the requirements a medical device organisation is audited against for Australia, Brazil, Canada, Japan and the United States: QMS planning and management, registration and change notification, CAPA and complaints, adverse event and recall reporting per jurisdiction, design control and cybersecurity, production, sterilisation, UDI, traceability and labelling, purchasing, and technical documentation. It comprises 79 controls organised across 8 domains, and applies in International.

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Where MDSAP Audit Approach (MDSAP AU P0002) overlaps with the standards you already hold

MDSAP Audit Approach (MDSAP AU P0002) vs ISO 27001:2022View comparison →MDSAP Audit Approach (MDSAP AU P0002) vs SOC 2View comparison →MDSAP Audit Approach (MDSAP AU P0002) vs NIST CSF 2.0View comparison →MDSAP Audit Approach (MDSAP AU P0002) vs GDPRView comparison →MDSAP Audit Approach (MDSAP AU P0002) vs HIPAAView comparison →MDSAP Audit Approach (MDSAP AU P0002) vs PCI DSS 4.0View comparison →

What MDSAP Audit Approach (MDSAP AU P0002) means in your sector

MDSAP Audit Approach (MDSAP AU P0002) for Healthcare→MDSAP Audit Approach (MDSAP AU P0002) for Financial Services→MDSAP Audit Approach (MDSAP AU P0002) for Technology→MDSAP Audit Approach (MDSAP AU P0002) for Government→MDSAP Audit Approach (MDSAP AU P0002) for Manufacturing→MDSAP Audit Approach (MDSAP AU P0002) for Energy→MDSAP Audit Approach (MDSAP AU P0002) for Retail→MDSAP Audit Approach (MDSAP AU P0002) for Education→

What MDSAP Audit Approach (MDSAP AU P0002) means for your job

MDSAP Audit Approach (MDSAP AU P0002) for CISOs→MDSAP Audit Approach (MDSAP AU P0002) for Compliance Officers→MDSAP Audit Approach (MDSAP AU P0002) for Risk Managers→MDSAP Audit Approach (MDSAP AU P0002) for IT Directors→MDSAP Audit Approach (MDSAP AU P0002) for DPOs→MDSAP Audit Approach (MDSAP AU P0002) for Auditors→

Questions people ask about MDSAP Audit Approach (MDSAP AU P0002)

What is MDSAP Audit Approach (MDSAP AU P0002)?
The MDSAP Audit Approach (MDSAP AU P0002.011) as the requirements a medical device organisation is audited against for Australia, Brazil, Canada, Japan and the United States: QMS planning and management, registration and change notification, CAPA and complaints, adverse event and recall reporting per jurisdiction, design control and cybersecurity, production, sterilisation, UDI, traceability and labelling, purchasing, and technical documentation.
How many controls does MDSAP Audit Approach (MDSAP AU P0002) have?
MDSAP Audit Approach (MDSAP AU P0002) contains 79 controls organized across 8 domains.
Where does MDSAP Audit Approach (MDSAP AU P0002) apply?
MDSAP Audit Approach (MDSAP AU P0002) applies in International. Organizations operating in or serving customers in this jurisdiction should check whether its requirements reach them.
Which version of MDSAP Audit Approach (MDSAP AU P0002) is covered here?
This page covers MDSAP AU P0002.011 Audit Approach, revision date 3 August 2026; with MDSAP AU P0038.002 (MDO eligibility pilot, effective 1 August 2026).

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MDSAP Audit Approach (MDSAP AU P0002), its 79 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.

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Written and maintained by Gerard Blokdyk, The Art of Service.Last updated .