MDSAP Readiness Assessment

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

BiotechHealthcare25 minutes22 questions

1. Management Responsibility

Does your quality policy address all MDSAP regulatory requirements (FDA, HC, TGA, PMDA, ANVISA)?*

Task 1 SOP 10001: Quality policy applicable to all jurisdictions

Are quality objectives established with measurable targets for each MDSAP market?*

Task 1 SOP 10002: Objectives consider regulatory changes and complaints

Does top management conduct scheduled reviews covering all regulatory requirements?*

Task 1 SOP 10003: Review includes input from all MDSAP jurisdictions

2. Resource Management

Are personnel competent in regulatory requirements for all target MDSAP markets?*

Task 2 SOP 20001: Training on jurisdiction-specific regulations

Is infrastructure maintained to meet the most stringent MDSAP requirements?*

Task 2 SOP 20002: Facilities, equipment, IT systems for all markets

Do you maintain regulatory intelligence for changes in all MDSAP jurisdictions?*

Task 2 SOP 20003: Monitor FDA, Health Canada, TGA, PMDA, ANVISA updates

3. Product Realization

Do design controls address requirements from all target MDSAP regulatory authorities?*

Task 3 SOP 30001: Design inputs include jurisdiction-specific requirements

Are risk management activities conducted per ISO 14971 and MDSAP requirements?*

Task 3 SOP 30002: Risk management throughout product lifecycle

Do you evaluate and control suppliers to MDSAP standards?*

Task 3 SOP 30003: Supplier controls meet all jurisdictions

Are production processes validated with documented evidence per MDSAP requirements?*

Task 3 SOP 30004: Process validation protocols and reports

Do you maintain device traceability throughout manufacturing and distribution?*

Task 3 SOP 30005: UDI and lot traceability per each market

4. Measurement & Analysis

Are internal audits planned to cover all MDSAP requirements annually?*

Task 4 SOP 40001: Audit program includes all regulatory elements

Do you analyze quality data from all markets to identify trends?*

Task 4 SOP 40002: Data analysis includes complaints, CAPAs, returns

Is nonconforming product controlled with disposition per each jurisdiction?*

Task 4 SOP 40003: NC control considers market-specific actions

5. Multi-Regulatory Requirements

Do you meet FDA 21 CFR 820 requirements including design controls?*

Task 5 SOP 50001: Full FDA QSR compliance

Do you comply with Health Canada CMDR requirements including MDL reporting?*

Task 5 SOP 50002: Canadian Medical Device Regulations compliance

Are TGA (Australia) requirements met including adverse event reporting?*

Task 5 SOP 50003: Therapeutic Goods Administration compliance

Do you meet PMDA (Japan) requirements for quality management?*

Task 5 SOP 50004: Pharmaceuticals and Medical Devices Agency (PMDA)

Are ANVISA (Brazil) requirements satisfied including registration and labeling?*

Task 5 SOP 50005: Brazilian Health Regulatory Agency requirements

6. Post-Market Surveillance

Do you have complaint handling procedures meeting all MDSAP timelines?*

Task 3 SOP 30006: Complaint investigation within regulatory timeframes

Are adverse events and incidents reported to all applicable authorities?*

FDA MDR, Canada MDL, TGA, PMDA, ANVISA reporting

Do you have procedures for recalls/field actions in all MDSAP markets?*

Task 3 SOP 30007: Market-specific recall procedures and notifications

Please answer all required questions to see your results