Alpha Quality Assurance
Experience counts. Alpha's principal,
Ken Miles (email@example.com), has 28 years experience as a
senior FDA medical device investigator. As an FDA consultant,
he can help you navigate the regulatory passageways to maintain
processes certification and lead you to device approval.
Ken Miles assists the medical device
industry in complying with FDA requirements. Ken's expertise
includes evaluating Good Manufacture Practice (GMP) and Good
Laboratory Practice (GLP) compliance, Quality System Regulations,
and QSIT certification inspections (Management, Design, Process
Controls, and CAPA).
He also specializes in sterilization
validation, in vitro diagnostic and radiological health
product (i.e. diagnostic x-ray imaging equipment, laser
systems, etc) performance standards. Ken Miles retired from
the US Food and Drug Administration as the Agency's Pacific Regional
Radiological Health Representative / Emergency Response
Coordinator and Medical Device Specialist.
His responsibilities included
technical assistance, comprehensive reports and recommendations to
management and technical staff regarding individual and
industry-wide compliance issues. His conducted medical device
inspections throughout the Western US, Canada, Europe and
His clients range from small start-up
companies to global corporations with domestic and foreign
manufacturing sites that produce a variety of medical device
products including x-ray imaging and therapeutic systems, surgical
instruments, catheters, in-vitro diagnostic (IVD) products.
- Mock FDA inspections with written reports with findings,
citations of regulations and requirements, and recommendations
- Conducts audits of radiation-emitting medical devices
(diagnostic and therapeutic x-ray imaging systems, laser
devices, ultrasound devices and other radiation-emitting
device) for conformance to Radiological Health performance
standards FDA 21 CFR 1000-1050
- Provides expertise to radiological
health manufacturers and importers for compliance with FDA's
performance standards for radiation-emitting products. Provides
written reports with findings, citations of regulations and
requirements, and recommendations.
- Reviews and makes recommendations
covering Quality Records such a Quality Manuals, procedures,
work instruction, and forms for conformance to FDA regulations
and International Standard Organization requirements
- Device and in-vitro diagnostic (IVD) Good Manufacturing
- Quality System Regulations (QSRs)
- Quality System Inspection Technique requirements (Design
Control, Management Control, Manufacturing and Process Controls,
CAPA, MDRs, Recalls, 21 CFR Part 11 (Electronic Records and
- Sterilization Validation.
- Compliance with QSR and International Standards Organization
- Gap analysis of documents for compliance of QSR and ISO
13485:2003 and ISO 14971 Risk Management requirements.
- Complaint handling, Medical Device Reporting (MDR) and
Correction and Removal programs and operations.
- Premarket Notification 510(k) documentation to FDA�s
Center for Devices and Radiological Health (CDRH).
- Assist device and pharmaceutical manufacturers with Good
Laboratory Practice and Clinical Study compliance.
- Provides presentations to industry on FDA related topics.
- Good Laboratory Practices audits
- Clinical study regulatory requirements
- Conducts ISO 14001:2004 Environmental Management System audits
- Regulatory Affairs Professional Society
- American Society for Quality, Biomedical Div., San Francisco
and Santa Clara Divisions
- Health Physics Society, Northern California / Sierra
Chapter, and San Francisco Bay Area Chapter
- American Association of Physicist in Medicine, San Francisco
- American Nuclear Society, Bay Area chapter