MDSAP QMS Gap Assessment
A Gap Assessment Should Predict Audit Exposure - Not Produce a 200-Line Checklist
An experienced MDSAP gap assessment examines documented requirements, implementation evidence and the regulatory consequences of process failure. A compliant-looking SOP is not enough if records demonstrate inconsistent execution or if the procedure does not trigger the correct country-specific regulatory action.
Our Gap Assessment Support Includes
- ISO 13485:2016 baseline and MDSAP process mapping
- Quality manual, SOP, work instruction and form review
- Management review and quality-objective evidence
- Internal audit program effectiveness
- CAPA and nonconformity control
- Complaint handling and reportability decision records
- Design control and design-change evidence
- Production, process validation and release records
- Supplier controls and outsourced-process governance
- Marketing authorization and facility-registration controls
- Jurisdiction-specific reporting, record and licensing requirements
- Cross-document consistency review
What the Auditor Is Really Testing
- Procedure-to-practice consistency across sampled operational records
- Objective evidence over a representative historical operating period
- Whether repeated gaps indicate a systemic quality management weakness
- Whether one weakness propagates into other linked MDSAP process areas
- Whether records prove effective control rather than administrative completion
How NKB Regovanta Approaches It
We classify gaps by audit exposure, regulatory significance and process propagation. A weak complaint process, for example, is not treated as one isolated finding because it may also compromise vigilance, CAPA, risk management, design change and management review. The remediation plan therefore addresses the system, not only the symptom.
Predict Your MDSAP Audit Exposure Today
Book an objective, senior-level MDSAP gap assessment with NKB Regovanta to uncover and remediate systemic QMS vulnerabilities.