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