What it is
What is MDSAP?
MDSAP is an international program developed under the International Medical Device Regulators Forum (IMDRF). Recognized auditing organizations perform one audit that covers the requirements of all participating jurisdictions:
- United States — FDA
- Canada — Health Canada
- Australia — TGA
- Brazil — ANVISA
- Japan — MHLW & PMDA
Why it matters
Why MDSAP compliance is important
- Maintains compliance with ISO 13485 plus country-specific requirements
- Builds trust with regulators across key markets
- Replaces multiple separate audits with one audit cycle
- Enhances transparency and consistency of regulatory processes
How we help
Our MDSAP services
- Gap analysis and readiness assessments
- QMS implementation per MDSAP and ISO 13485 requirements
- Internal audits and mock MDSAP audits
- Documentation preparation and audit support
- Continuous compliance monitoring and updates
01
Expert consultants
Deep experience with global regulatory systems and MDSAP audit models.
02
Customized solutions
Services tailored to your product and target markets.
03
End-to-end support
Complete documentation through to audit defence.
04
Proven approach
A structured methodology used on successful MDSAP implementations.
The regulatory journey
From regulatory strategy to MDSAP approval
- 01Framework identificationWe confirm the regulatory pathway that applies to your product and target market — MDSAP, MDR, FDA, TGA or MHRA.
- 02Regulatory strategyDevice classification, pathway selection and a realistic timeline to support launch planning.
- 03Technical documentationRisk management, clinical/performance evidence, labeling and QMS records built to each authority’s expectations.
- 04Submission and liaisonWe prepare and submit the application, manage questions from the authority or Notified Body, and track progress.
- 05Approval and market accessClearance, CE or UKCA marking, ARTG inclusion or registration, enabling your product to be placed on the market.
- 06Post-market complianceOngoing surveillance, vigilance, periodic updates and renewals to maintain compliance.
