Medical Devices
Medical Devices
We are capable of providing end-to-end services for device product development including developing Design input requirements (System to sub-system level), Design Verification and Design Validation protocols/reports, Design History File creation, Design Outputs, Design Transfer, Process Validation, Test method validation, and 510k submissions.
Case Studies:
Design History File Remediation
- Remediation of multiple product families for disposable medical devices such as IV sets, stop-cocks, manifolds, Pressure monitoring lines, and Luer-activated devices
- Creation of Design verification protocols/reports and Design Validation protocols and reports per specified requirements
- Remediation of Risk Management file for disposable products
Infusion pump Risk management Files per ISO 14971
- Creation of software Hazard Analysis for Infusion pump based on IEC 62304
- Creation of the Risk Management Plan, Hazard Analysis, DFMEA, and Use/Misuse FMEA for a pressure monitoring device based on ISO 14971
Quality System Integration for a Medical Device Company
- Creation of Quality procedures for integration to comply with ISO 13485, focusing on CAPA, Nonconformance, Post-market surveillance, Risk Management, Design Inputs, Design Outputs, Design Transfer, Design Verification, and Design Validation.
Product Development Process Procedures
- Creation of Global SOPs in compliance with 21 CFR 820.30 for each of the elements of Design Inputs, Design Outputs, Design Reviews, Design Verification, Design Validation, Design Transfer, Design Changes, and Design History File
Quality Systems
- Quality Systems Management
- CAPA / Root cause Analysis
- Product Complaint Handling
- Trending
- Post-Market Surveillance
- Quality Plan
- Field Actions
- Nonconformance management
Research & Development
- Combination Product Development
- Design Engineering
- Mechanical Engineering
- Electrical Engineering
- Product development
- Systems Engineering
- Risk Management
Manufacturing
- Test Method Validation
- Process Validation
- Equipment Validation
- Utility System Validation
- Cleaning Validation
- Validation Master Plans
- Computer System Validation
Compliance Management
- Consent Decree / Warning Letter Remediation
- Design History File Remediation
- Quality System Audits
- Audit Responses
- Technical File/DD/MDR/ Remediation