Medical Device Quality and Regulatory Compliance
Navigate Complex Regulatory Landscape to Launch and Sustain, Safe and Effective Products
Quality Management System FDA QMSR, ISO 13485 Quality System Design and Implementations, CAPA
We help establish QMS and Systems with Metrics and Process Monitoring
Quality Audits and Validations Quality System and Due diligence audits, Process Validation, Statistics
We help Internal and External Audits. We help Verifications and Validation
Services
Regulatory Compliance Regulatory Strategy and Intelligence, Submission (510(k), PMA, De Novo)
We help Product Approvals, and Warning Letter Remediation
Supply Chain Management Supplier Sourcing and Qualification, Material Validations
We help Material Sourcing and Qualification
New Product Development Design and Development Files, Medical Device Files, Risk Management
We help Design History Files and Risk Management
Data Management Data Integrity and Cybersecurity Assessment
We help Data and Cybersecurity Assessments and Mitigations
Value Proposition
Improved Quality and Safety
We improve QMS that enhances patient outcome
Faster time to Market
We plan and execute streamlined compliance to accelerate launch
Cost Savings
We provide savings through Cost effective audits, Process Optimization and Projects
Lower Regulatory Risk
We remediate Regulatory Non-conformance and establish strong Design, Purchasing and Complaint Management
Framework
We help Maintain and Sustain Compliance To