FDA medical device audits


ISO 13485

ISO 13485 matrix

ISO 14001

Professional links 1

Professional links 2

About/contact us



Alpha Quality Assurance provides these professional links as a service to the medical device industry


Alpha Quality Assurance Associates
111 Nataqua Avenue
Pacifica, CA 94044
Phone 650.359.4297
Fax 650.359.6171

Professional links (2)


21 CFR

510(k) Information & Releasable Database

510(k) Paradigm

CDRH Home Page

CDRH Databases

CDRH Standards Program

CDRH Referral List

Index of CDRH Web Documents

Product Classification Database

Registration Searchable Database

Listing Searchable Database

Contacts Listing Database

Premarket Approval Database

Code of Federal Regulations (CFR)

Consumer Information/CDRH

Device Advice DSMICA Staff Directory

Electronic Products Radiation Control

Export of Medical Devices

Federal Food, Drug, and Cosmetic Act

Federal Science Website

FDA Home Page

FDA's' Centers Small Business Contacts

Global Harmonization

Good Guidance Practices (GGP)

International Program


Medical Device Reporting Home Page

Medical Device Exemptions

Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

Medical Device Listing

Premarket Approval

Premarket Notification (510(k))

Establishment Registration and U.S. Agent

Reuse of Single Use Devices 

Third Party Review Program

Alpha Quality Assurance  111 Nataqua Ave   Pacifica, CA 94044  650.359.4297

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