Find Suppliers
Consultants Directory on Medical Device Link Index
Alpha Quality Assurance Associates
111 Nataqua Ave.
Pacifica, CA 94004
Tel: 650/359-4297
Fax: 650/359-6171
Contact: Ken Miles
Year Established: 2004
Web: AlphaQA.biz
E-mail: kenmilesaqa@earthlink.net
|
Update
this company's information |
Description:
Led by former FDA investigators, Alpha Quality Assurance Associates provides expert consulting services for U.S. and foreign manufacturers of medical devices, IVD products, and radiological health devices such as x-rays and lasers. Services include site audits, gap analysis, and recommendations for QSR, GLP, and ISO 13485:2003 requirements, documentation, and practices. The company has expertise in FDA compliance issues, MDRs, recalls, electronic records, validation, and radiological health performance standards.
Categories this company is listed under in the Consultants Directory on Medical Device Link:
- Audits/Inspections (43 companies)
- Good Manufacturing Practices/Compliance (53 companies)
- Quality Assurance (47 companies)
- Regulatory Affairs (51 companies)
- Sterilization (14 companies)
