The standards you are audited against

Certify your device quality management system to the standard registrars and regulators expect

Comply with the FDA's device quality rule, built on ISO 13485 since February 2026

Meet the manufacturer's obligations the notified body audits before and after CE marking

Be audited once for five regulators, Canada's among them

Run device risk management from hazard to residual risk, the way every regulator expects it

Conform to the lifecycle standard for device software, from requirements to maintenance

Clear a device for the US market by showing it is substantially equivalent to one already sold

Compile the file a notified body assesses before a device is CE marked, and keep it current after

Comply with the FDA's manufacturing regulations for finished pharmaceuticals

Comply with EU GMP as the member states' inspectors read it, Chapters 1 to 9

Meet EU GMP's requirements for the computerised systems that hold your records

Comply with GMP for active pharmaceutical ingredients, from the starting material on

Present pharmaceutical development and quality by design the way the assessor reads it

Assess, control and review quality risks with the reasoning the inspector asks to see

Run a pharmaceutical quality system across the product lifecycle, as Q10 describes it

Develop and manufacture drug substances the way the application has to describe them

Comply with good clinical practice as sponsors, CROs and sites are inspected against it

Comply with the FDA's rules for human cells, tissues and cellular and tissue-based products

Be accredited as a tissue bank against the AATB Standards

Be accredited as a medical laboratory for quality and competence

Be accredited as a testing or calibration laboratory

Keep electronic records and signatures the FDA accepts

Certify a quality management system beside the industry standards you hold

Certify an information security management system your customers' questionnaires ask for

Certify a privacy information management system for the personal data you hold

Certify an AI management system for the AI in your product or your processes