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I Am Lean

5.0 (1 review)
Closed • 9:00 am - 6:00 pm

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Business consulting

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4 years ago

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Fang Consulting - Welcome to Fang Consulting, experts in regulatory affairs consulting and quality system consulting.

Fang Consulting

(1 review)

There are reviews out there I don't agree with. I have know Tracy Eberly for years. My wife is a…read moreneurosurgeon who has worked with many of the products Fang Consulting has helped get "online". Tracy is one of the most tolerant men I know. He might be vocal in his political beliefs, which might anger some, but Fang Consulting does good work. Don't let obscure reviews change the impression of Fang. Some people want to hurt those who are vocal which they disagree with. Instead of confrontation, they leave bad reviews. They would not be able to win an argument if they actually had to be in person.

From the owner: * Regulatory Affairs Consulting (medical) * Quality…read moreSystem Consulting * Pre-market notification FDA 510(k)'s * Investigational Device Exemptions (pre-IDE and IDE) * Pre-market Approval (PMA) applications * Product Development Protocols (PDP) * Post-market surveillance protocols * Labeling * Establishment registration and device listing * Medical Device Reporting (MDR) and complaint handling * CE marking, Vigilance reporting, Standards and guidelines * FDA regulatory agency meetings * Selection and interpretation of US and international quality system requirements * Drafting ISO 13485 quality manuals and procedure * Conducting gap analyses, pre-audits, and internal audits * Developing Medical Device Reporting (MDR) and European vigilance reporting systems * Performing regulatory audits * Preparing Technical Files and Design Dossiers * Manage Quality Systems for virtual companies * Communications for product field actions (safety alerts, product recalls, corrective actions)

I Am Lean - businessconsulting - Updated May 2026

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