MDSAP Readiness Review
Panabistics performs a mock audit-style readiness review for manufacturers preparing for MDSAP certification, surveillance, recertification, transfer, remediation, or audit response.
Part of Panabistics Regulatory Readiness Stress Tests. Navigating the Future of MedTech Compliance.
MDSAP audits assess whether the quality management system is implemented, effective, risk-based, and supported by objective evidence across key processes and country-specific regulatory requirements. Panabistics reviews your audit readiness by challenging whether your records, procedures, CAPAs, complaints, design controls, supplier controls, production controls, post-market processes, and management oversight can withstand audit scrutiny.
MDSAP is not simply an ISO 13485 document review. It uses a linked, process-based audit approach built on risk management and incorporates applicable jurisdiction-specific regulatory requirements. The readiness review challenges whether your procedures, records, objective evidence, and process linkages can withstand auditor scrutiny.
Risk management is the foundation of the MDSAP process approach. The review also evaluates how findings, complaints, CAPAs, supplier issues, design changes, production controls, and postmarket signals connect across the QMS.
The review scope is tailored to the markets relevant to the manufacturer. MDSAP incorporates applicable regulatory requirements from the participating authorities in addition to the underlying medical-device quality-management-system requirements.
The European Union, Singapore Health Sciences Authority, the United Kingdom Medicines and Healthcare products Regulatory Agency, and the World Health Organization Prequalification of In Vitro Diagnostics Programme participate as official observers. The applicable readiness-review scope will be defined based on the manufacturer’s markets, products, certification status, and audit objectives.
Review Scope
Deliverables
Structured findings focused on likely audit questions and evidence weaknesses.
Practical tracker organized by QMS process, severity, and remediation ownership.
Identification of gaps against participating MDSAP regulatory authority expectations.
Anticipated evidence requests to validate implementation and effectiveness before audit day.
Risk-prioritized roadmap to address audit risks and close evidence gaps.
Support to strengthen procedures, records, and CAPA evidence, scoped separately as needed.
Audience
This service does not replace an MDSAP audit, certification body audit, regulatory authority inspection, legal advice, or the manufacturer’s responsibility for QMS compliance. It is an independent readiness review designed to identify audit risks and evidence gaps before formal audit activity.
Request a Review
Tell us about your QMS scope, audit timeline, prior findings, and participating markets. We will respond within 24 business hours to discuss scope and next steps.