YOUR PROJECT SCOPE: NEW PRODUCTS & PROCESSES SEEKING PRE-MARKET APPROVAL
Product and Process Development of New Medical Devices including In-Vitro Diagnostic (IVD) Testing Kits or Medical Devices with Emerging Technologies (e. g. Artificial Intelligence, 3D-Additive Manufacturing, etc.) that are subject to Premarket Application (PMA) Submissions with U. S. Government Regulating Agency with an Emphasis in Applicable Regulations in terms of Controls of Product and Process Designs.
OUR CONSULTING SCOPE
The Company Provides Technical Management Consult in Design Input Requirements, Design Verifications, and Design Validations for Both Products and Manufacturing Processes to Ensure Product Safety and Effectiveness and Manufacturing Quality for Securing PMA Approvals.
YOUR PROJECT SCOPE: CURRENTLY MARKETED PRODUCTS WITH QUALITY DIFICIENCIES
Complaint Handlings for Currently Marketed Medical Devices Including IVD Testing Kits and their Supply Chains that are Subjected to U. S. Government Regulating Agency’s Regulatory Actions such as Objectionable Condition Observations, Administrative Warnings, and Court Actions for Applicable Law and Regulation Violations.
OUR CONSULTING SCOPE
The Company Provides a Comprehensive Review of Client Companies’ Operations in Product and Process Design Controls including Change Controls, Complaint Handlings, Supplier Controls, Employee Training, Equipment Calibration and Maintenance, Environmental Monitoring, Product Labeling and Packaging Controls, End-User Training, and Quality Management Controls for Medical Device Reporting (MDR) and Reports of Corrections and Removals. The Company Provides Root-Cause Analysis and Recommendations for Corrective and Preventive Actions (CAPAs). The CAPAs include but not limited to: a) Product Design Changes; b) Process Design Changes; c) Test Method Changes or New Test Method Development and Requirements; d) Material Controls, and e) Product Packaging and/or Labeling Changes.
We Address Prolonged Time-to-Market for Your New Products and Processes
We Help You Overcome Your Companies' Regulatory Hurdles
We Bring Your Revenue Back Up and Build Profitability for Sustained Growth
Access Experienced Technical Management for Development Project Directions.
Obtain Technical Guidance on Example-to-Examble Basis
Gain Confidence in Decision Making with Quality Data Analysis.
Communicate Directly with All Functional Heads for Corrective Action Initiatives.
How It Works
A. PROJECT PROPOSAL
B. REQUIREMENT ANALYSIS
C. SALES AGREEMENT
E. PROJECT FOLLOW UP POST COMPLETION
D. VIRTUAL OR ON-SITE PROJECT
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