A large medical device company had a mature commercial medical device used for scientific research that recently received approval for clinical use. With an MDSAP audit looming and quality systems that were not built for international regulation, the organization had to move fast. USDM's assessment and remediation services made the company MDSAP audit-ready in just four months.
The Challenge
A newly formed Quality leadership team determined that the governing policies and procedures were significantly inadequate for the international regulations and standards required for their plans to design, develop, and distribute medical device products. Additionally, an MDSAP audit was looming and the organization was not sufficiently prepared for it.
- Global medical device company with a newly acquired Quality leadership team
- A commercial medical device used for scientific research had received approval for clinical use
- Needed to assess existing quality management policies and procedures and document gaps against regulations, standards, open CAPAs, and corporate requirements
- Needed to prepare for an imminent Medical Device Single Audit Program (MDSAP) audit
- Needed to develop and harmonize international quality management policies and procedures across design, manufacturing, and labeling
The strategic nature and aggressive timeline of the engagement required a partner with deep quality management expertise who could rapidly assess the current set of policies, procedures, work instructions, forms, and templates and revise or replace significant components to align with FDA 21 CFR Part 820 and related regulations, ISO 13485:2016, and MDSAP. Establishing strong data integrity across these records was foundational to demonstrating audit readiness.
The Approach
USDM developed and executed a plan to prepare the organization for MDSAP, grounded in a structured, risk-based remediation methodology.
- Quality management policies and procedures were assessed, updated, and harmonized — delivered on-time and on-budget
- Implemented consistent naming and numbering conventions for documents and records
- 35 policies and procedures created or updated to align with MDSAP, 21 CFR Part 820, and ISO 13485:2016
- 55 work instructions and 144 forms and templates created or updated
- Delivered the organization's first comprehensive GMP training
A Foundation for Sustained Compliance
The remediation did more than satisfy a single audit. By harmonizing documentation and establishing clear conventions, USDM gave the Quality leadership team a durable foundation for continuous compliance as the device moved further into clinical use. Modern quality programs increasingly pair this kind of documentation rigor with risk-based validation approaches such as computer software assurance (CSA) and 21 CFR Part 11 compliance for electronic records and signatures.
The Results
- MDSAP-ready in 4 months from initiation to approvals
- 230+ policies, procedures, work instructions, and forms updated and harmonized
- First comprehensive GMP training delivered across the organization
- Document naming and numbering conventions standardized for ongoing control
By assessing, remediating, and harmonizing the company's quality management system on an aggressive timeline — and on budget — USDM turned an under-prepared organization into one ready to stand in front of an MDSAP audit. The result is a quality system aligned to international standards and built to support the device's growth into clinical use. Connect with USDM to prepare your organization for its next regulatory audit.