Medical Device Services
Pre-Approval inspection readiness
SPS assembled a team consisting of following roles:
FDA Inspection resulted in ZERO 483 Observations
- Review of PMA to align readiness with submission
- 100 day meeting preparation
- Develop Action Plan to mitigate risk
- Manage the readiness program from filing to inspection
- Assist in drafting responses to audit observations
- Develop Remediation plans
- Manage remediation efforts to completion
- Design
- Implementation
- Training
- Identify Quality Systems Gaps
- Remediate Gaps
- New
- Existing
Design Controls & CAPA
Services Include the following- Develop study designs, engineering analysis and lab study reports
- Design Verification Testing
- Design Control Review
- Design History File Review, gap assessment and remediation
- Statistical Analysis Techniques & expertise in analyzing Min-Tab Data
- Supplier Quality Audit
- Develop and Review Non Conformance (NCR) Reports
- CAPA work stream Management
- - Conduct Root Cause Analysis
- - Recommend and implement Preventive Action
Case Study-Gastric Balloon System Manufacturer
Smart Pharma Solutions (SPS) was contracted to assist with PMA review and QSR inspection readinessSPS assembled a team consisting of following roles:
- Ex-FDA Medical Device National Expert
- Quality Systems Expert
- Program Manager
- Quality Engineer
- Medical Device Validation Engineers
- Reviewed Pre-Market Approval Application
- Assessed Current State (Gaps, Risk) wrt Test Method Validation, Process Validation, Design Controls, Internal Audit and Supplier Quality Management Program
- Develop Continuous Improvement Action Plan
- Enhanced existing procedures (Statistical Sampling, Test Method Validation, Internal Audit and Supplier Management)
- Identified Test Methods to be validated, authored TMV protocols and executed them
- Identified Design inputs/Output gaps, enhanced Design Controls & Assembled Design History File
- Drafted PPQ report and a Program Report
FDA Inspection resulted in ZERO 483 Observations