Fang Consulting
3640 Pillsbury Ave.
Minneapolis, MN 55409
Phone: (612) 716-1209
FAX: (612) 821-6662
Contact: Tracy Eberly
Biomedical Field
Regulatory affairs consulting for the medical device industry
Business
Services
Services
International
- IEC 60601: UL 2601-1, CAN/CSA C22.2 No. 601.1, and EN 60601-1
- 93/42/EEC: Medical Device Directive
- IEC 878: Graphical Symbols for Electrical Equipment in Medical Practice
- EN 1441: Medical Devices - Risk Analysis
- EN 794-1: Lung ventilators - Part 1: particular requirements for critical care ventilators
- EN 601-1-4: Medical Electrical Equipment -- Programmable Medical Electrical Systems
Domestic
- Investigational device exemption (IDE) applications
- Pre-market notifications [510(k)s]
- Pre-market approval (PMA) applications
- Reviewing and Developing Instruction Manuals and Other Labeling for FDA Compliance
Other Services
- Preparing CE Mark technical files for new products
- Revising files after TUV or FDA audits
- Writing test plans, protocols and procedures
- Executing design verifications and validations
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