Marielle Lejcher Email

Senior Regulatory Affairs Consultant . Fang Consulting

Current Roles

Employees:
48
Revenue:
$12M
About
Fang Consulting handles the Regulatory Affairs, Clinical Affairs, and Quality activities for Medical Device manufacturers. We specialize in US and OUS submissions for Class II and III medical devices. We also set up and manage CFR 820 and ISO 13485 compliant Quality Systems. At Fang Consulting, you have the ability to source the team that fits your needs. Fang excels in providing combinations of Sr. Level and Jr. Level team members. Let us manage your project, help control your costs and ensure your success. Areas of Service: MDR Impact Assessment MDR Quality System Gap Assessment Design Document Gap Assessment Gap Response Plan Clinical Evaluation Reports Mock Audit - EU MDR Notified Body Submission / Response Post - Market Surveillance Services On-Site MDR Training
Fang Consulting Address
2800 Patton Rd
Minneapolis, MN
United States
Fang Consulting Email

Past Companies

Fang ConsultingSenior Regulatory Affairs Consultant
Starkey HearingPrincipal Regulatory Affairs Engineer
Beckman Coulter DiagnosticsStaff, Regulatory Affairs

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