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Waxler Regulatory Consultancy LLC
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1920
Arlington Place, Madison, WI 53726 (608) 219-7547 mwaxler@charter.net
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I provide consultant services on Food and Drug Agency regulatory issues for the entire life cycle of your medical
devices including, but not limited to: - Is your product regulated by FDA?
- Is
your product regulated as a device, a drug, a biologic, or some combination?
- Do you need pre-market authorization
from FDA?
- What kind of pre-market authorization is required?
- Are you in compliance with Design Controls and
other aspects of FDA Quality Regulations?
- Are your claims for your product within the bounds of the product classification?
- Has
the agency cited your company for deficiencies?
- Are your complaint handling processes and procedures compliant?
- Do
you have an FDA inspection process?
Our services include: - Assessment
of FDA component of business plans.
- Preparation and review of premarket applications.
- Review
of adequacy of Design Controls.
- Preparation and gap analysis of compliance with Quality System Regulations.
- Preparation
for meetings with the agency.
- Opinion letters regarding regulatory status of your products.
We provide FREE ESTIMATES...give us a call.
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Resume - Founded Waxler Regulatory Consultancy LLC in 2008 to continue my practice of providing FDA
regulatory advice after 26 years at FDA and nearly 7 years at law firms.
- Completed five successful years with
the FDA Consulting Practice at Godfrey & Kahn, a law firm in Madison, WI. Formulated regulatory strategies for a
wide range of medical products including cardiovascular implants, combination products, ophthalmic devices, and antibiotic
biologics. Also served for six months as compliance officer for a major manufacturer of cardiovascular devices to assure
compliance with a Corporate Integrity Agreement with the Department of Health and Human Services.
- Successfully formulated
and implemented regulatory strategies for more than 60 manufacturers of a wide range of medical products in 22 months at Hogan
& Hartson, a law firm in Washington, DC and elsewhere. The products included demineralized human bone, human cultured
skin, tissue-based wound dressings, vascular and biliary stents, orthopedic and spinal implants, reagents, and many other
products.
- Four years as an innovative manager at FDA regulating eye, ear, nose and throat devices.
- Successfully
developed consensus within FDA on regulatory, engineering, and clinical guidance for manufacturers seeking marketing approval
of lasers for refractive surgery (LASIK).
- Eighteen years of successful facilitation of organizational transitions
with FDA.
- Two years experience successfully mediating workplace disputes with the Federal government.
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