Device safety, quality management systems, in-vitro diagnostics, and post-market surveillance requirements for medical device manufacturers. AuditDSS decomposes 64 regulations into 36,541 individually testable obligations across 9 jurisdictions with 4-axis risk scoring.
FDA Warning Letters, consent decrees, and EU MDR enforcement are accelerating. One quality system failure can halt your entire product line and trigger a worldwide recall.
$646M
HHS-OIG device enforcement
Olympus Corp paid $646M for kickback schemes to sell endoscopes — Anti-Kickback violations in device sales trigger criminal prosecution
$557M
FDA enforcement actions
Warning Letters, import alerts, and consent decrees — a single 483 observation can cascade into a facility shutdown
EU MDR
European enforcement emerging
MDR 2017/745 reclassification is pulling thousands of devices into higher-risk categories — non-compliance means losing CE marking
64
Regulations covered
3,611
Rules decomposed
36,541
Obligations scored
9
Jurisdictions
9 jurisdictions, 64 regulations
From FDA Quality System Regulation (21 CFR 820) to EU MDR Annex requirements, from UDI labeling to post-market surveillance — AuditDSS decomposes every regulation into independently testable obligations.
Score your entire QSR program — design controls, CAPA, production controls, and complaint handling — in a single assessment. See exactly which 483 observations are waiting for you.
Your OEM customers demand QSR compliance evidence. Demonstrate obligation-level conformance across production controls, process validation, and supplier management without months of manual documentation.
FDA holds importers responsible for device compliance. UDI labeling, MDR reporting, and complaint handling obligations apply to you — not just the manufacturer. Know your exposure.
All 64 regulations applicable to medical devices & diagnostics, grouped by theme. Every regulation links to its detailed obligation breakdown.
Therapeutic Goods Administration
Centers for Medicare & Medicaid Services
European Parliament and Council
European Parliament and Council
Food and Drug Administration
FDA Center for Devices and Radiological Health
Medicines and Healthcare products Regulatory Agency
Office of the Australian Information Commissioner
California Attorney General / California Privacy Protection Agency
European Data Protection Board
HHS Office for Civil Rights
Data Protection Board of India
Personal Data Protection Commission
Information Commissioner's Office
Cyber and Infrastructure Security Centre
Joint Committee of European Supervisory Authorities (EBA/ESMA/EIOPA)
Center for Internet Security
European Union Agency for Cybersecurity
National Institute of Standards and Technology
National Institute of Standards and Technology
New York Department of Financial Services
PCI Security Standards Council
National Cybersecurity Authority
Cybersecurity and Infrastructure Security Agency
General Services Administration
HITRUST Alliance
American Institute of Certified Public Accountants
HHS Office of Inspector General
European Parliament and Council
US Department of Justice — FCPA Unit
Agence Française Anticorruption
Committee of Sponsoring Organizations of the Treadway Commission
Securities and Exchange Commission
Centers for Medicare & Medicaid Services
Serious Fraud Office
Australian Securities and Investments Commission
European Parliament and Council
European Parliament and Council
International Sustainability Standards Board
International Sustainability Standards Board
Safe Work Australia
European Parliament and Council
Occupational Safety and Health Administration
Occupational Safety and Health Administration
Health and Safety Executive
Fair Work Commission
Australian Border Force
Ministry of Human Resources and Social Development
Equality and Human Rights Commission
Advisory, Conciliation and Arbitration Service
Independent Anti-Slavery Commissioner
U.S. Department of Labor — Wage and Hour Division
U.S. Department of Labor — Wage and Hour Division
Equal Employment Opportunity Commission
American Institute of Certified Public Accountants
Information Systems Audit and Control Association
Committee of Sponsoring Organizations of the Treadway Commission
Cloud Security Alliance
International Auditing and Assurance Standards Board
International Auditing and Assurance Standards Board
American Institute of Certified Public Accountants
American Institute of Certified Public Accountants
Answer a few questions about your business. Get a complete compliance program — policies, procedures, and operational forms — tailored to your risk profile and mapped to every obligation. Ready in minutes.
Medical Devices & Diagnostics Compliance Policy
Risk-calibrated · 10–15 sections
Operational Procedures
Step-by-step · Staff-ready
Forms & Checklists
Operational forms · Ready to use
Score your existing policies against 36,541 obligations — or generate a complete compliance program tailored to your business in minutes.