A large medical device company had a mature commercial medical device used for scientific research that recently received approval for clinical use. A newly formed Quality leadership yeam determined that the governing policies and procedures were significantly inadequate for international regulations and standards 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.

The strategic nature and aggressive timeline of the engagement required a company with expertise in quality management who could rapidly assess their current set of policies, procedures, work instructions, forms, and templates and revise or replace significant components to be aligned with FDA 21 CFR part 820 and related regulations, ISO 13485:2016, and MDSAP. USDM’s assessment and remediation services helped the company to be MDSAP audit-ready in just four months. 

The Situation

• Global medical device company with a newly acquired Quality Leadership Team
• A commercial medical device used for scientific research received approval for clinical use
• Needed to assess existing quality management policies and procedures and document gaps with regulations, standards, open CAPAs, and corporate requirements
• Needed to prepare for an imminent Medical Device Single Audit Program (MDSAP) 
• Needed to develop and harmonize international quality management policies and procedures including design, manufacturing, and labeling