Gap Analysis

We begin with a comprehensive MDSAP gap assessment that evaluates your current quality management system against.

• ISO 13485 requirements 
• MDSAP audit model processes 
• Applicable country-specific regulatory requirements 

This phase identifies compliance gaps, audit risks, and priority actions, forming the foundation of your MDSAP implementation roadmap. 

Establish an MDSAO-Compliant Quality Management System (QMS)

Next, we help you establish or refine a medical device QMS aligned to ISO 13485 and MDSAP requirements.
This includes: 

• Quality manual and regulatory procedures 
• Defined roles and regulatory responsibilities 
• Risk-based documentation aligned to audit expectations 

Your QMS is designed to withstand process-based MDSAP audits, not just meet minimum documentation requirements. 

Process Owner and Management Alignment 

MDSAP audits place heavy emphasis on management responsibility and process ownership. During this phase,
we: 

• Review procedures with process owners 
• Validate implementation against real-world operations 
• Align leadership accountability with MDSAP expectations  

This ensures your documentation reflects how your organization actually operates—critical for audit success. 

Implement the MDSAP QMS

With alignment complete, we guide your organization through full QMS implementation,
ensuring: 

• Procedures are actively followed 
• Records and objective evidence are generated 
• Risk management, CAPA, and change controls are fully embedded 

This phase focuses on audit-defensible implementation, not theoretical compliance. 

MDSAP Internal Audit

We conduct an internal audit aligned to the official MDSAP audit model, not a generic ISO audit.
This includes: 

• Process-based audit sequencing 
• Regulatory authority-specific sampling 
• Identification of high-risk nonconformities 

This phase prepares your team for the structure, depth, and intensity of an actual MDSAP audit. 

MDSAP Auditing Organization Audit – Stage 1

Your selected MDSAP Auditing Organization (AO) conducts the Stage 1 audit to confirm. 

• Readiness for the full MDSAP audit 
• QMS maturity and documentation completeness  

We support you in addressing findings and closing gaps before moving forward.  

MDSAP Audit – Stage 2 & Certification 

Stage 2 evaluates the full implementation and effectiveness of your QMS against the MDSAP audit model.
Upon successful completion:

• Nonconformities are addressed and closed 
• Your organization earns MDSAP certification 
• Regulatory authorities recognize audit results 

Ongoing Compliance and MDSAP Maintenance 

MDSAP certification is not a one-time event. We support ongoing compliance through.

• Surveillance audit preparation 
• Regulatory change management 
• Continuous improvement and CAPA effectiveness 
• FDA and Health Canada inspection readiness