Quality Management Systems

We provide hands-on support to medical device, pharma, and biotech companies in the areas of FDA quality system regulation (QSR) and International Organization for Standardization (ISO) quality management system compliance. We scale the quality system effort to the needs of the company, its products, and its culture.


 
Assessments, GAP Analyses, and Optimization

Reviews of process and procedures to identify opportunities for improvement.

 
Implementation and Turn-key Project Management

Complete management of projects from task execution, resource planning, schedule management, team meetings, etc.

 
ISO Certification & Product CE Marking

Lead efforts to achieve regulatory approvals for product commercialization.

 
Management Responsibility Training and Coaching

Provide guidance and counsel for senior Management regarding responsibilities related to Quality Management System execution.

 
Deviation and CAPA Management

Remediation of product and production issues through deviations, Out Of Spec occurrences, and implementation of actions to address recurrence of failures.

 
Mock Regulatory Agency (FDA, Notified Body, etc.) Audits and Inspections

Perform activities to simulate audit situations and questioning to prepare organizations for the real thing.