MDSAP Regulatory Strategy & Scope Assessment
Start With Scope Before You Start Rewriting Procedures
MDSAP audit scope drives the entire readiness strategy. Before remediation begins, the manufacturer needs a clear view of the legal manufacturer, audited sites, product families, design and manufacturing activities, outsourced processes, critical suppliers, service activities and regulatory jurisdictions that will fall within the certification scope.
Our Scope Assessment Support Includes
- Legal manufacturer and site-scope assessment
- Product-family and technology mapping
- Design, manufacturing, service and distribution activity mapping
- Outsourced process and contract-manufacturer assessment
- Applicable-jurisdiction determination (US, Canada, Brazil, Japan, Australia)
- Certification scope and certificate wording review
- Existing ISO 13485 / MDSAP audit history review
- Open CAPA, complaint, recall and regulatory-action review
- Audit-cycle planning: initial, surveillance and re-audit readiness
- Readiness timeline based on actual remediation risk rather than an arbitrary audit date
What the Auditor Is Really Testing
- Whether declared scope matches actual activities and products
- Whether outsourced activities remain effectively controlled by the manufacturer
- Whether market declarations are complete and current across all 5 participating jurisdictions
- Whether QMS responsibilities and interfaces are clear across internal and external sites
- Whether records outside the corporate SOP set can be sampled without exposing scope gaps
How NKB Regovanta Approaches It
We create an audit universe before detailed remediation. This identifies the sites, processes, products, jurisdictions and record populations that an auditor could reasonably sample. It prevents the common mistake of polishing procedures while leaving supplier files, production evidence, regulatory registrations or post-market records inconsistent with the certification scope.
Ready to Establish Your MDSAP Audit Scope?
Connect with NKB Regovanta's senior MDSAP advisors to map your legal manufacturer entities, product lines, and multi-country certification parameters.