Medical Device Product Development

Medical Device Product Development, Engineering, R&D, FDA Submissions and Manufacturing. Engineering Services • Concept Brainstorming & Development • CAD & Drafting Services • FEA • Prototyping • Component Sourcing • Specifications (Components & Assemblies) • Verification Testing & Reports • Packaging Design & Validation • IP Research • Project Management • Documentation • Quality System (Auditing, SOP Revision, Systems Implementation, Training) • Design Validation • Design Reviews • Risk Analysis • Design FMEA Validation Services • Validation Master Plan Development • Project Management • Factory and Site Acceptance Testing (FAT, SAT) • Start-Up and Commissioning • Installation, Operational, and Performance Qualification • Protocol Execution • Summary & Final Report Development • Standard Operating Procedures (SOP) Development • Quality Audits Areas of Quality and Regulatory Affairs support: Over 400 -510k Submissions since 1974 -Auditing Quality System Compliance 
-CE Mark Compliance 
-Create and Review Product Change "Letters to File"
-FDA Facility Registration and Device Listing 
-FDA Good Manufacturing Practices (GMP), Quality System 
-FDA Quality System Audit Inspection Support 
-FDA Regulation Interpretation and Guidance
-International Regulatory Compliance 
-In Vitro Diagnostic Device Directive Compliance and Support 
-Medical Device Directive Compliance and Support 
-Medical Device Reporting and Complaint System Compliance 
-Pre-Clinical, Clinical Design and Implementation 
-Quality and Regulatory Affairs Management
-Quality System Registrar Interface, Quality System Selection 
-Recall Strategy Development and Implementation
-Reply to FDA Inspection Observations Form 483 
-Submission Strategy and Implementation 
-United States Agent for Foreign Manufacturer of Medical Devices

• Employees7
• Founded1974