MyRHC Compliance index

FDA · IMDRF

MDSAP Readiness Assessment

Evaluate readiness for Medical Device Single Audit Program certification covering FDA, Health Canada, TGA, PMDA, and ANVISA requirements in one audit

Medical Device Biotech & Life Sciences Healthcare US

At a glance

Short name
MDSAP
Issuing / stewarding body
FDA, IMDRF
Jurisdiction
US
Also known as / related labels
ISO 13485 · FDA 21 CFR 820 · Canada CMDR · TGA · PMDA · ANVISA

What this entry covers

Evaluate readiness for Medical Device Single Audit Program certification covering FDA, Health Canada, TGA, PMDA, and ANVISA requirements in one audit

MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid — it is not legal advice and is not a substitute for the official text.

Official documentation

How to use this index entry

  1. Open the official link above (or the agency home if the deep link drifts).
  2. Confirm edition / revision date against your program scope.
  3. Map applicability by sector and jurisdiction listed in the metadata.
  4. Follow related frameworks only after checking their own official sources.

Disclaimers

  • MyRHC does not host proprietary standards text (ISO, some industry bodies).
  • Where standards are paywalled, we link to the publisher’s catalog page.
  • Always verify current requirements with counsel and the issuing authority.
Index only — not legal advice. MyRHC does not certify compliance. Confirm current requirements with the issuing authority and qualified counsel. Proprietary standards text remains with its publisher.

Same agencies or sectors — still verify each official source independently.

FDA 820

Official

FDA 21 CFR Part 820 QSR Assessment

Evaluate compliance with FDA Quality System Regulation for medical device manufacturers - the U.S. equivalent of ISO 13485

FDA Medical Device Biotech & Life Sciences

FDA Part 11

Official

FDA 21 CFR Part 11 Electronic Records Compliance

Evaluate compliance with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures in FDA-regulated industries

FDA Healthcare Biotech & Life Sciences

FDA AI/ML

Official

FDA AI/ML Software as Medical Device (SaMD)

Evaluate FDA AI/ML-based Software as Medical Device compliance per 2021 guidance, covering predetermined/adaptive algorithms, algorithm change …

FDA AI & Machine Learning Medtech

FDA DSCSA

Official

FDA Drug Supply Chain Security Act (DSCSA)

Evaluate DSCSA compliance for pharmaceutical track-and-trace, serialization, verification, and transaction history requirements

FDA Supply Chain Pharma

mHealth Apps

Official

FDA Mobile Health App Compliance

Evaluate mobile medical app compliance with FDA guidance, 21 CFR Part 11, data security, clinical validation, and app store requirements

FDA Telehealth & Digital Health Medtech

GCP

Official

Good Clinical Practice (GCP) Compliance Assessment

Evaluate compliance with international ethical and quality standards for clinical trial design, conduct, and reporting

FDA ICH Clinical Research Biotech & Life Sciences