Regulatory FDA CFR 820 and European MDR Strategy Classification Regulatory Pathway Clinical Strategy Reimbursement Strategy CRO Selection and Management Pre-market Submissions Traditional 510(k)s De Novo 510(k)s IDEs PMAs CE Marking Technical Files and Design Dossiers Clinical Evaluation Reports (CER) Clinical Submissions IDEs IRB/Ethics Committee Nonconformance and Remediation CAPAs 483 Warning Letters Audit Observations Audits Pre-Certification Mock Inspections Supplier Quality QMS & QMS Support Quality Strategy Plan Design Implementation Team Training Support Interim Program Management DHF Compilation and Maintenance Internal Process and Quality System Audits Supplier Assessment CAPAs Adverse Event (AE) Vigilance (MDR/MDVR) Gap Analysis Document Control Activities Risk Management Activities Labeling/UDI Verification and Validation Software Process Equipment Cleaning & Sterilization Packaging & Labeling Facilities Engineering Our engineering team comprises experts in: Mechanical Engineering Electrical Engineering Software Development Catheter Engineering Human Factors & Usability Systems Engineering Biomedical Engineering Material Science Manufacturing Engineering Collectively, we deliver solutions in the following areas: Research Product Strategy Concept Generation Requirements Development Design Development DFx Design Verification New Product Introduction Pilot Manufacturing Contract Manufacturer Management
