Some of Our Services

Medical Device Design

Medical Device Design

Medical Device Design

Project management
Concept generation and product definition
Design and development updates (models, drawings, etc.)
FEA and engineering evaluation
Vendor management
Manufacturing and testing quotes and facilitation
Design control documentation updates
Engineering changes review and approval

QUALITY ASSURANCE

Medical Device Design

Medical Device Design

Quality Systems
QMS Compliance & Remediation
QMS Design, Implementation, and Training
Quality Management Systems Auditing

REGULATORY AFFAIRS

Medical Device Design

REGULATORY AFFAIRS

Regulatory Submission Strategy
FDA Registered US Agent
FDA Submissions & Post-Market Obligations
CE Mark Submissions & Post-Market Surveillance
International Regulatory
Risk Management
Manufacturing Compliance
Clinical Evaluation Reports