Mock MDSAP Audit by Former FDA Investigators

Stress-test your QMS against the 5-jurisdiction MDSAP model.
Identify Grade 4 and 5 risks before your AO arrives.

Our 7-Process Audit Methodology.

Chapter Title Focus Area
Chapter 1 Management The Foundation. Auditors check if leadership provides enough resources and if the “Management Review” actually finds and fixes systemic problems.
Chapter 2 Device Marketing Authorization & Facility Registration The License. Verification that your company is legally registered and your devices are cleared/approved in all 5 jurisdictions (US, CA, BR, AU, JP).
Chapter 3 Measurement, Analysis, and Improvement The CAPA Engine. This is the most scrutinized chapter. It looks at how you handle non-conformities, complaints, and internal audits to drive change.
Chapter 4 Medical Device Adverse Events & Advisory Notices Reporting Vigilance. Auditors check your “Stopwatch.” Do you report deaths or serious injuries within the strict timelines of each specific country (e.g., 48-hour or 10-day rules)?
Chapter 5 Design and Development The Blueprint. A deep dive into your Technical Files. They check if user needs were actually met and if design changes were properly validated.
Chapter 6 Production and Service Controls The Floor. This covers manufacturing, sterilization, and equipment calibration. They look to see if the product made on the floor matches the design specs.
Chapter 7 Purchasing The Suppliers. Assessment of how you control your vendors. In 2026, there is a massive focus here on Critical Suppliers and software-as-a-service providers.
RA QA Compliance

Don’t risk a Grade 4 or 5 non-conformity. Leverage the "Investigator Mindset" to stress-test your QMS against the 5-jurisdiction MDSAP model before your Auditing Organization arrives.

The MDSAP Stakes in 2026

Under the Medical Device Single Audit Program, a single systemic failure is no longer a local issue. A high-risk finding triggers mandatory notifications across the USA, Canada, Brazil, Australia, Japan, and Malaysia.

At RAQA.ch, we don’t just “audit”—we simulate. Led by former FDA investigators, our mock audits provide the technical scrutiny and psychological preparation necessary to protect your global market access.

Our MDSAP Audit Methodology

We mirror the official MDSAP Audit Model (AU0019). Our process follows the 7-process sequence to identify the “inter-process” gaps that internal teams often miss.

  1. The 7-Process Chapter Simulation
  • Management & Purchasing: We evaluate leadership commitment and the increasingly complex 2026 supplier risk-management requirements.
  • Device Marketing Authorization: Verification of registration compliance for all five participating jurisdictions.
  • Measurement, Analysis, & Improvement (CAPA): A deep dive into your data sources to find the “hidden” trends that auditors target.
  • Adverse Events & Advisory Notices: Testing your reporting triggers against RDC 665/2022 (Brazil) and CMDR(Canada).
  • Design & Production: Bridging the gap between design inputs and manufacturing outputs for high-risk devices.
  1. Jurisdiction-Specific Gap Analysis

MDSAP is not a “generic” ISO 13485 audit. We test for the specific country requirements that lead to most findings:

  • FDA QMSR (USA): Seamlessly transitioning your 21 CFR 820 logic to the new ISO-based FDA requirements.
  • Health Canada: Strict adherence to SOR/98-282 requirements.
  • ANVISA (Brazil): Verification of technical file requirements and local GMP.
  • TGA & MHLW: Compliance with Australian and Japanese-specific regulatory nuances.

The Ex-FDA Advantage: “The Backroom Simulation”

An audit is 50% technical compliance and 50% presentation. Our mock audits include:

  • Frontroom/Backroom Coaching: Teaching your Subject Matter Experts (SMEs) how to answer directly without over-disclosing.
  • The Grading Scale Predictor: We score your non-conformities on the official 1-to-5 scale, allowing you to prioritize “Grade 4” risks immediately.
  • Direct Investigator Insight: We look for the “red flags” that former FDA officials are trained to spot.

 

Jurisdiction Critical Focus Point for Our Mock Audit
USA (FDA) Alignment with 21 CFR 820 and the new QMSR.
Canada (HC) Compliance with CMDR SOR/98-282 (Crucial for Class II+).
Brazil (ANVISA) RDC 665/2022 requirements for Good Manufacturing Practices.
Australia (TGA) Therapeutic Goods (Medical Devices) Regulations 2002.
Japan (MHLW) MHLW Ordinance No. 169 and PMDA requirements.

MDSAP Readiness FAQ

Why hire a former FDA investigator for an MDSAP audit? 

MDSAP auditors follow a rigid “Audit Sequence.” Former investigators understand the intent behind the sequence, allowing them to find systemic weaknesses in CAPA and Management that standard consultants miss.

Does RAQA.ch cover all five MDSAP jurisdictions? 

Yes. Our audits cover the specific regulatory requirements for the USA, Canada, Brazil, Australia, and Japan, ensuring your QMS is harmonized globally.

How long is a typical Mock MDSAP Audit? 

A comprehensive simulation typically requires 3 to 5 days, depending on the number of sites and the risk classification of your devices.


    Contact RAQA by ex-FDA Investigator

    Understanding MDSAP makes a difference.

    Use the 5 jurisdictions (USA, Canada, Brazil, Australia, Japan) and briefly list the specific regulation (e.g., RDC 665/2022) you will audit against.

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