One Way Consulting, LLC, is a Medical Device Consulting firm whose mission is to help get your device to the market sooner, to assure your quality systems meet FDA requirements, and solve any FDA issues in a timely and successful manner.
Consulting Services:
- Create FDA Strategic Plans for Start Up Companies
- Serve as Regulatory / Quality Mentors
- Liaison at FDA to Solve Regulatory Issues
- Perform MOCK FDA Audits to Assess Quality Systems
| - Prepare Responses to FDA-483 Observations / FDA Warning Letters
- Review Design Control Operations for Required Elements
- Evaluate CAPA Programs for Effectiveness and Compliance
- Perform Webinars on FDA Issues / Provide Expert Witness Services
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Principal, John Lawrence Stevens, RAC, has over 20 years of FDA Regulatory Compliance experience encompassing virtually all FDA field positions. He also has 18 years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the Medical Device Industry, including several large and small cardiovascular companies.
Mr. Stevens has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel which reviewed over 30 PMA clinical studies for cardiovascular devices. He regularly perform webinars regarding FDA and issues regarding Clinical Studies and Medical Devices.
View Mr. Stevens' Expert Witness Profile.
