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