MDSAP CONSULTING & AUDIT PREPARATION
Prepare one connected system for your MDSAP audit.
MDSAP preparation brings the quality system and applicable country requirements into the same operating processes. ES³ Solutions helps medical-device organizations identify gaps, strengthen evidence, and prepare the people responsible for demonstrating how the system works.
A shared QMS with applicable market requirements.
Build readiness around processes and their connections.
An ISO 13485 certificate provides useful context, but it does not answer every MDSAP readiness question. Your organization needs to understand which market requirements apply, where they are implemented, and how records connect across management, product realization, suppliers, complaints, and corrective action.
When this support is useful
- You are preparing for an initial MDSAP audit or expanding your market scope.
- Your ISO 13485 QMS needs assessment against applicable country requirements.
- Teams need to understand the MDSAP process-based audit approach.
- Previous findings require clearer corrective actions and effectiveness evidence.
Scope of support
Work defined around your needs.
Choose a focused assessment or a broader implementation engagement. The scope and deliverables are agreed before work begins.
01
Scope & gap assessment
Review products, activities, markets, and existing QMS evidence against the agreed MDSAP criteria.
02
QMS integration
Help incorporate applicable market requirements into existing processes and records, with clear responsibilities.
03
Audit preparation & coaching
Support process-owner preparation, evidence organization, and focused readiness assessments based on the agreed audit scope.
04
Finding-response support
Help interpret findings, investigate causes, develop actions, and prepare evidence for the organization's response.
Planning the engagement
A clear scope. Realistic priorities.
Preparation depends on QMS maturity, the markets in scope, site structure, previous findings, and availability of operating records. We define the work around those conditions and your audit schedule. ES³ Solutions provides consulting and preparation; the recognized Auditing Organization conducts the certification audit.
You work directly with the experienced consultant responsible for understanding the issue and delivering the agreed work.
What you can expect
- A defined market and process scope for preparation
- A prioritized assessment of QMS and evidence gaps
- An implementation plan for applicable market requirements
- Process-owner coaching and evidence-preparation support
- Corrective-action support for agreed findings
How the work progresses
From understanding to effective action.
01
Scope
Identify products, activities, and markets.
02
Connect
Integrate applicable requirements.
03
Demonstrate
Prepare process owners and records.
04
Improve
Address findings and verify actions.
Questions before you begin
Practical answers. A clearer starting point.
These answers provide general context. The right approach depends on your products, operations, and applicable requirements.
How is an MDSAP audit different from an ISO 13485 audit?
MDSAP uses a defined audit approach that combines the ISO 13485 QMS framework with relevant requirements of participating regulatory authorities. Preparation therefore needs to consider process connections and applicable country requirements, not only the standard.
Which regulatory authorities participate in MDSAP?
The program's five member jurisdictions are Australia, Brazil, Canada, Japan, and the United States. Other authorities participate as observers or affiliate members. Their participation should not be treated as identical acceptance of an audit report in every market.
How long does MDSAP preparation take?
The answer depends on the starting point. A mature system with well-maintained evidence needs different support from an organization implementing new processes or resolving significant findings. An initial assessment allows the work, dependencies, and timing to be defined.
Does MDSAP replace medical-device market authorization?
No. MDSAP addresses quality-system auditing. Product registration, licensing, and other market obligations remain subject to the requirements of each jurisdiction. The intended markets and activities determine the preparation scope.
Can ES³ Solutions conduct the MDSAP certification audit?
ES³ Solutions provides gap assessments, preparation, training, and remediation support. MDSAP certification audits are conducted by recognized Auditing Organizations. Consulting support and the certification decision are separate.
Regulatory references
Reinforce the work with your team
Build the understanding to sustain the improvement.
Help your team understand the audit approach, applicable market requirements, and how evidence connects across processes. Process-owner coaching can reinforce the changes made during preparation.
Connected support
Related services
Let’s define the practical next step.
Tell us what you need to accomplish, where the difficulty sits, and any timing constraints. We can discuss the support that fits your organization.