F&D Group provides testing, consulting, and training services to support medical device manufacturers in successfully completing FDA registration and ensuring compliance with U.S. regulatory requirements.
1. Testing Services
(1) Biocompatibility Testing (ISO 10993 / USP Class VI)
· Cytotoxicity
· Skin Irritation
· Intracutaneous Reactivity
· Skin Sensitization
· Acute Systemic Toxicity
· Pyrogenicity
· Implant Testing
(2) Electrical Safety & Electromagnetic Compatibility (EMC) Testing
· Electrical Safety (IEC 60601-1 / ANSI AAMI ES 60601-1)
· Electromagnetic Compatibility (EMC) (IEC 60601-1-2)
· Medical Device Software Validation (IEC 62304)
· Cybersecurity Testing
(3) Mechanical Performance & Physical Testing
· Mechanical Strength Testing for Passive Implants (e.g., stents, bone screws, catheters)
· Fatigue, Torsion, and Tensile Testing (ASTM F2516, ASTM F543)
· Flow Rate Testing for Infusion & Injection Systems (ISO 8536, ISO 7864)
(4) Sterilization & Microbiological Testing
· Sterilization Process Validation (ISO 11135 / ISO 17665 – EtO, Steam, Gamma Radiation, etc.)
· Sterility Testing (ISO 11737)
· Bacterial Endotoxin Testing (LAL Test, USP <85>)
(5) In Vitro Diagnostic (IVD) Performance Testing
· Sensitivity, Specificity, and Cross-reactivity Validation (FDA 21 CFR 809)
· Precision & Repeatability Assessment (CLSI Standards)
2. Consulting Services
(1) Regulatory Compliance & Registration Strategy
· Product Classification & Regulatory Pathway Selection (Class I, II, III)
· 510(k), De Novo, and PMA Registration Strategy
· Establishment Registration & Product Listing
· FDA QSR (21 CFR Part 820) Compliance Assessment
(2) Technical Documentation Support
· 510(k) Submission Preparation
· De Novo/PMA Technical Documentation Support (clinical trials, risk assessment, etc.)
· Risk Management File Development & Optimization
· Product Labeling & Instructions for Use (IFU) Review
(3) Quality Management System (QMS) Consulting
· FDA QSR (21 CFR 820) Compliance Audit
· Supplier Audits & Quality Control System Improvement
(4) Clinical Trials & Biostatistical Analysis
· Clinical Trial Design (IDE Submission)
· Clinical Data Analysis & Statistical Evaluation
· Institutional Review Board (IRB) Approval Support
(5) Market Access & Post-Market Surveillance (PMS)
· Adverse Event Reporting (MDR)
· Product Recall Management
· FDA Warning Letter Response Strategies
3. Training Services
(1) FDA Regulations & Registration Process Training
· Overview of FDA Medical Device Regulations (21 CFR Part 807/820)
· 510(k), De Novo, and PMA Certification Pathways
(2) Technical Documentation & Compliance Training
· Guidelines for Preparing 510(k) Submissions
· Risk Management & Clinical Evaluation Training
· Post-Market Surveillance (PMS) Training
(3) Product Testing & Standards Training
· Biocompatibility Testing (ISO 10993 / USP) Training
· Electromagnetic Compatibility (EMC) & Electrical Safety (IEC 60601-1-2) Training
· Sterilization Validation (ISO 11135 / ISO 17665) Training
(4) Clinical Trial & Post-Market Compliance Training
· FDA Clinical Trial (IDE) Design Training
· Adverse Event Reporting (MDR) & Recall Management Training
· FDA Facility Inspection Readiness Training
Name:Ms. Li
Telephone:+86 15701209486
Address:Room 2005, Building No. 2, House No. 60 of Xinhuaxijie Street, Tongzhou District, Beijing, China
Email:fdgroup2024@163.com
Copyright © 2025 BEIJING FDPHOENIX京ICP备2025117674号-1