MedTech Results helps to bring medical device products to the U.S. market by developing practical regulatory paths to commercialization. From early-stage design planning, to manufacturing and product distribution, to post-market activities, MTR performs the following Client services to support FDA regulatory submission and product distribution in the U.S.  

• Device & Materials Analysis
• Software Functions Evaluation
• Product Classification (P-codes)
• Testing and Validation planning
• Intended Use
• Risk Analysis
• Substantial Equivalency Reports
• Training
• Labeling & Packaging
• FDA Facility Registration & Product Listing
• Manufacturing Planning & Supplier Evaluation
• Quality System (FDA Sec 820 QSR) implementation
• Pre-Submissions (Q-Subs), 510(k) Submissions, de Novo applications

All MTR work conforms to FDA requirements in 21 CFR Part 820, the Quality System Regulation (QSR), and also applicable standards of ISO 13485 (Medical Devices), ISO 14971 (Risk Assessment), and ISO 62304 (Medical Software). We know about FDA’s Recognized Consensus Standards. And we’ve got you covered for HIPAA, 100%.