FDA Consulting, LLC

Specialties

I enjoy the challenge of aligning the research, regulatory, quality systems, clinical and marketing plans with the shared goal of delivering to the marketplace validated products that benefit both the patient and the clinician.

* 25 years of experience in FDA regulated industry (medical devices and in vitro diagnostics).

* Domestic and international regulatory compliance submissions.

* Classification, conformity assessment and technical documentation.

* Broad experience with multiple FDA product classifications: cardiovascular, nuclear medicine, general surgery and orthopedic medical devices; clinical chemistry, microbiology, immunology and hematology devices in a variety of formats (IHC, ELISA, IFA, lateral flow, genotyping).

* ISO 13 485

* FDA 510k

* 21 CFR 820

History

Established in 2014.

25 years of experience in FDA regulated industry (medical devices and in vitro diagnostics).

* Domestic and international regulatory submissions.

* Classification, conformity assessment and technical documentation for CE marking of multiple products regulated under the Medical Devices and In Vitro Diagnostic Medical Devices Directives.

* Successful management of FDA inspections and Notified Body audits of the quality management system.

* Broad experience with multiple FDA product classifications: cardiovascular, nuclear medicine, general surgery and orthopedic medical devices; clinical chemistry, microbiology, immunology and hematology devices in a variety of formats (IHC, ELISA, IFA, lateral flow, genotyping).

* Direct experience assisting manufacturers to achieve certification to ISO 13 485:2003.

* Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professionals Society in both US and EU.

*Accredited lead auditor for medical device quality systems by ANSI-​RAB.

Meet the Business Owner

Michael W.

Business Owner

25 years of experience in FDA regulated industry

www​.fda​-con​sult​ing​.com