MDSAP AUDIT READINESS & CONSULTING
Prepared for 5 Jurisdictions. Trusted for Quality.
We help medical device manufacturers build a robust QMS, prepare for MDSAP audits and achieve certification that opens doors to global markets.
MDSAP Readiness
Process-Based Approach
5 Jurisdictions Aligned
Stronger QMS Outcomes
Global Market Access
MDSAP
One Audit. Multiple Markets.
Prepare Your QMS for One Connected Regulatory System Across Jurisdictions
MDSAP readiness is not achieved by adding five country names to an ISO 13485 procedure. A successful audit requires the manufacturer to demonstrate that its quality management system actually operates as one connected regulatory system — from management responsibility and design controls through supplier management, production, complaints, CAPA, adverse-event reporting, product registrations and post-market actions.
The goal is not to make the QMS look compliant for audit week. The goal is to build a system in which an auditor can select a complaint, CAPA, design change, supplier issue or production record and follow the evidence across functions without finding contradictory decisions, missing regulatory assessments or weak ownership.
5 Participating Regulatory Jurisdictions
MDSAP audits are conducted by recognized Auditing Organizations (AOs). Participating Regulatory Authorities use MDSAP audit outputs according to their own national laws and regulatory programs.
AUSTRALIA
Therapeutic Goods Administration
BRAZIL
Agência Nacional de Vigilância Sanitária
CANADA
Mandatory for Class II, III & IV Licences
JAPAN
Ministry of Health, Labour & Welfare
UNITED STATES
Accepts MDSAP in Lieu of Routine QSIT Inspections
The 7 MDSAP Process Areas
A clause-by-clause ISO 13485 checklist can miss the most important audit risk: process interaction. MDSAP preparation tests whether evidence moves correctly between these seven process areas.
Management
Executive responsibility, quality policy, resource management, and management review effectiveness.
Measurement, Analysis & Improvement
Internal audits, CAPA systems, nonconformity control, and statistical trending.
Design & Development
User needs, design inputs, verification, validation, risk management, and DHF design transfer.
Production & Service Controls
Process validation (IQ/OQ/PQ), DHR batch release, cleanroom controls, and equipment calibration.
Purchasing & Supplier Controls
Critical supplier qualification, quality agreements, outsourced processes, and incoming verification.
Device Marketing Authorization & Facility Registration
Market licensing maintenance, establishment listings, and national registration alignment across 5 markets.
Adverse Events & Advisory Notices Reporting
Statutory adverse event reporting, vigilance timelines, and Field Safety Corrective Action (FSCA) execution.
OUR MDSAP CONSULTING SERVICES
Click on any consulting module below to access dedicated subpages detailing methodology, auditor expectations, and execution roadmaps.
MDSAP Regulatory Strategy & Scope Assessment
Define audit scope, product categories, applicable jurisdictions, legal manufacturer boundaries, and regulatory expectations.
MDSAP QMS Gap Assessment
Detailed gap assessment against ISO 13485:2016 and MDSAP specific requirements across all 7 process areas.
MDSAP Process-Based Audit Readiness
Evaluate readiness across all 7 MDSAP process areas with a risk-based, evidence-driven audit trail approach.
ISO 13485 to MDSAP QMS Alignment
Align your QMS to MDSAP expectations beyond ISO 13485 including regulatory overlays of all 5 jurisdictions.
Country-Specific Regulatory Requirements
Address additional regulatory requirements for Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (PMDA) & USA (FDA).
Mock MDSAP Audits & Interview Preparation
On-site or remote mock audits, detailed reporting, auditor-style interviews, record retrieval drills, and management briefings.
Design & Development Control Readiness
Ensure design controls, risk management (ISO 14971), V&V, software lifecycles, and DHF are audit-ready and evidence-rich.
Production, Supplier & Process Validation
Strengthen manufacturing controls, critical supplier management, cleanliness, sterilization, and process validation evidence.
Complaint, Vigilance & Post-Market Readiness
Build systems for complaint handling, trend analysis, statutory adverse event reporting, and multi-country FSCA readiness.
Nonconformity, CAPA & Remediation Support
Root cause analysis, effective systemic CAPA, trend prevention, extent assessments, and remediation strategy until closure.
Audit Documentation & Evidence Preparation
Review and strengthen SOPs, records, forms, and objective evidence packages for seamless contemporaneous sampling.
Audit Response & Post-Certification Support
Support during audit, management of findings, response packages for Auditing Organizations, and continuous surveillance readiness.
THE MDSAP AUDIT JOURNEY
Structured step-by-step milestones from initial scoping to certification and ongoing surveillance
Assess Scope & Strategy
Gap Assessment
Readiness & Remediation
Mock Audit & Management Review
Certification Audit
Surveillance & Continuous Improvement
WHY CHOOSE NKB REGOVANTA?
- Deep regulatory & QMS expertise across all 5 MDSAP jurisdictions
- Led by senior ex-auditors and former medical device regulatory specialists
- Process-based, risk-focused approach mirroring Auditing Organization methodologies
- Practical, actionable, and sustainable QMS solutions without administrative bloat
- End-to-end support till certification grant, surveillance, and multi-year maintenance
Be Ready. Be Confident.
Be MDSAP Certified.
Prepare once. Get accepted across 5 major regulatory markets worldwide without repetitive audits.
What Makes an MDSAP Audit Difficult?
- An auditor can dynamically expand sampling when one single record suggests a broader quality process weakness.
- Country-specific statutory requirements are tested inside operational workflows, not as a separate regulatory matrix presentation.
- Complaint and CAPA audit trails quickly expose design, supplier, manufacturing, vigilance, and management review gaps.
- Outsourced activities remain the legal manufacturer’s absolute responsibility and create significant audit exposure.
- Inconsistent records across RA, QA, R&D, manufacturing, and post-market functions are often far more damaging than a weak individual SOP.
- Remediation that corrects only the sampled example leads to repeat findings because the underlying control system remains broken.
The Single Question That Determines MDSAP Success
“The strongest MDSAP preparation asks one question repeatedly: if an auditor selects this record and follows it upstream and downstream, will every linked process show the same controlled regulatory story? That is the rigorous standard we apply when preparing medical device manufacturers.”
Frequently Asked Questions
Is MDSAP the same as ISO 13485 certification?
No. ISO 13485 provides the core medical device quality management system framework, while MDSAP uses a defined audit approach that incorporates specific statutory and regulatory requirements from all five participating jurisdictions (Australia, Brazil, Canada, Japan, and the United States). A manufacturer can hold an ISO 13485 certificate and still require substantial MDSAP-specific readiness and documentation alignment.
Does MDSAP certification authorize a device for sale in all five countries?
No. MDSAP is a quality management system audit program. Product registrations, device marketing authorizations (e.g., US FDA 510(k)/PMA, Health Canada MDL, ANVISA Registro, TGA ARTG Inclusion, PMDA Shonin), establishment licensing, and local representation requirements remain subject to each jurisdiction’s distinct regulatory framework.
Who conducts the MDSAP audit?
MDSAP audits are conducted exclusively by recognized Auditing Organizations (AOs) — such as BSI, TÜV SÜD, DEKRA, DQS, Intertek, SGS, and UL. Participating Regulatory Authorities recognize and utilize the audit reports and certifications issued by these AOs in accordance with their own national laws and regulatory programs.
Do we need all five countries in scope for our MDSAP audit?
No. The applicable regulatory requirements depend entirely on the jurisdictions relevant to the manufacturer’s current and planned market commercialization activities. However, the audit scope must be defined precisely at the outset to ensure all relevant country-specific requirements are embedded into operational procedures.
What is the biggest mistake companies make when preparing for MDSAP?
The most frequent mistake is preparing documents rather than preparing the operating quality system. MDSAP auditors sample real operational records and follow evidence across interconnected processes (e.g., following a complaint through adverse event assessment, CAPA, risk file review, and design change). Procedures must be supported by consistent, traceable implementation evidence.
Can you prepare us if we already have ISO 13485 certification?
Yes. In this situation, NKB Regovanta focuses on MDSAP process logic, regulatory overlays, objective-evidence gaps, jurisdiction-specific controls (e.g., FDA 21 CFR 820 / QMSR, Health Canada licensing linkages, ANVISA Resolution RDC 665/2022, MHLW Ordinance 169), and audit behavior rather than rebuilding the entire foundational QMS.
Can NKB Regovanta conduct a formal mock MDSAP audit?
Yes. We conduct full-system or targeted mock audits simulating the exact MDSAP Audit Approach sequence. Our senior auditors challenge process owners, conduct live record retrieval drills, follow cross-process evidence chains, and provide a prioritized remediation roadmap before your recognized Auditing Organization arrives.
Can you support nonconformity and CAPA responses after our MDSAP audit?
Yes. We assist manufacturers in structuring robust nonconformity responses: containment, extent-of-condition assessment, root-cause analysis, systemic corrective action, implementation evidence packages, and effectiveness verification criteria to achieve full clearance with your Auditing Organization.
How should we prepare process owners for MDSAP auditor interviews?
Process owners should understand their process purpose, key risks, regulatory triggers, interfaces, and record retrieval paths. Memorized scripts fail during process-based audits; our interview coaching teaches process owners how to confidently explain workflows, demonstrate control, and retrieve objective evidence efficiently.
How do we maintain continuous audit readiness after MDSAP certification?
We help manufacturers integrate MDSAP requirements into internal audit schedules, management reviews, regulatory change monitoring, CAPA trending, and engineering change control. This ensures ongoing surveillance audit readiness without needing emergency remediation before annual visits.
Regulatory Basis: Structured around ISO 13485:2016, the current MDSAP Audit Approach and associated MDSAP audit-program documents, together with the applicable medical-device regulatory requirements of Australia (TGA), Brazil (ANVISA), Canada (Health Canada), Japan (MHLW/PMDA), and the United States (FDA).
Your MDSAP Regulatory & QMS Readiness Partner
Whether preparing for initial certification, converting from ISO 13485, or preparing for surveillance audits, NKB Regovanta supports the complete MDSAP lifecycle.