Quality System Remediation
Whether under official or voluntary action indicated, Regulatory Compliance 黄人导航庐 (RCA) routinely develops and executes scalable, defendable Quality System remediation plans for medical device manufacturers.
Regardless of an organizations size, we have engaged with clients to assist in the development of a compliant quality management system as a result of an inspection finding. Firms have relied upon our third party expertise to negotiate systemic Warning Letter corrective action plans, monitor and assess implementation of corrective actions, and remediation efforts.
With a proven track record of success, we have significant experience with the development of meaningful responses with sustainable corrective actions to:
- FDA 483 Observations
- Warning Letters
- Untitled Letters
- Consent Decrees
Our clients depend on us for:
- Preparation of a response that will be accepted by the Agency and be realistic for your organization to execute
- Development of a comprehensive proof book and preparation strategy
- Identify systemic versus discrete concerns, assess their technical validity, and frame comprehensive responses
- “Right size” corrective actions commensurate with organization size, capability and product risk
