Medical Device Services

Pre-Approval inspection readiness
  • 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
Post-Inspection Follow up
  • Assist in drafting responses to audit observations
  • Develop Remediation plans
  • Manage remediation efforts to completion
Assist device manufacturer’s in their Quality Systems
  • Design
  • Implementation
  • Training
Evaluate existing Quality Systems for QSR compliance
  • Identify Quality Systems Gaps
  • Remediate Gaps
Test Method, Instrument, Equipment and Software Validation
  • 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
Support management during external inspections and participate in the management of external inspections as requested / required

Case Study-Gastric Balloon System Manufacturer

Smart Pharma Solutions (SPS) was contracted to assist with PMA review and QSR inspection readiness

SPS assembled a team consisting of following roles:
  • Ex-FDA Medical Device National Expert
  • Quality Systems Expert
  • Program Manager
  • Quality Engineer
  • Medical Device Validation Engineers
SPS worked with the Medical Device Manufacturer Leadership Team (C-Level executives):
  • 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