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