A Global Medical Device Company selected RCM to take on the assessment and remediation efforts of its Cardiac Pump manufacturing line on fixed-price basis.
OBJECTIVE
A Global Medical Device Company selected RCM to take on the assessment and remediation efforts of its Cardiac Pump manufacturing line on fixed-price basis.
Initial Goal:
- Assess, document and communicate the current compliance state of Cardiac Pump manufacturing line, identify the compliance gaps and necessary remediation action, execute the validation/remediation effort (validation for 20+ systems).
Expended Goals:
- Assess compliance gaps and execute the validation/remediation efforts for 11 projects, including equipment and cleaning validation, and Intra-Aortic Catheter manufacturing line validation/remediation. Assess compliance gaps and execute a full validation of their manufacturing facilities.
SOLUTION
RCM provided three highly effective delivery teams consisting of 5-8 SMEs to address a total of 12 projects on a fixed-price basis. The teams were responsible for:
- Executing and documenting the regulatory assessment of the systems and the facility in scope and identifying the gaps and remediation activities.
- Defining and implementing the compliance solutions to meet Form 483 demands. The implemented solutions included the full validation of Catheter and Cardiac Pump manufacturing lines, as well as full facilities validation.
BENEFITS
- RCM efforts allowed the Client to gain control over their response to FDA observations and to reliably pass recurring FDA audits.
- RCM met the aggressive project compliance, quality, and delivery goals, on time and within budget.
Key Project Elements
Assessment & Remediation Action
Validation Execution
Compliance Solutions
Auditing Passivity
Regulatory & Quality Control