|
|
Osteometer
MediTech, Inc.
12515 Chadron Ave.
Hawthorne, CA 90250, USA.
Tel: +1 310 978 3073
Toll free: 866 421 7762
Fax: +1 310 676 0948
E-mail: info@osteometer.com
|
|
|
|
|
|
|
|
Osteometer maintains a proactive quality management
system, to provide safe and effective products
and assure customer satisfaction. The quality
management system is inclusive of all aspects
of the business, including design, manufacturing,
and delivery. Products are designed to provide
reliable and accurate service.
Osteometer is licensed to manufacture medical
devices by the FDA and the State of California, Department
of Health Services, Food and Drug Branch. As a
license holder, the company is regularly inspected
for conformance to good manufacturing practice
(GMP) and state law.
In addition to compliance with the 21 CFR 820
Quality System Regulations, Osteometer is also
certified as meeting the ISO
13485 : 2003
quality system requirements, and CE marking
certification for it's devices.
Osteometer is also certified to be in compliance
with the Medical Device Directive 93/42/EEC. Osteometer retains LNE/G-Med as a registrar
and notified body.
Devices sold by Osteometer comply with FDA Regulations
as applicable to Medical Devices 1020.30, GMP
Regulations(CFR 1020.30 (where applicable) of
the US Food and Drug Administration), CE Marking
Requirements and in compliance with ISO-13485 Standards
|
|
93/42/EEC |
|
Medical Device Directive annex II
|
|
|
IEC
60601-1 |
|
Medical electrical equipment.
Part 1: General requirements for safety
|
|
|
IEC
60601-1 |
|
Medical electrical equipment.
Part 1: General requirements for safety
-
1. Collateral standard: Safety requirements
for medical electrical systems
|
|
|
IEC
60601-1-2 |
|
Medical electrical equipment.
Part 1: General requirements for safety
-
2. Collateral standard: Electromagnetic
compatibility - Requirements and tests
|
|
|
IEC
60601-1-3 |
|
Medical electrical equipment.
Part 1: General requirements for safety
-
3: Collateral standard: General requirements
for radiation protection in diagnostic
X-ray equipment.
|
|
|
IEC
60601-2-7 |
|
Medical electrical equipment -
Part 2-7: Particular requirements
for the safety of high-voltage generators
of diagnostic X-ray generators.
|
|
|
IEC
60601-2-28 |
|
Medical electrical equipment. Part
2-28: Particular requirements for
the safety of X-ray source assemblies
and X-ray tube assemblies for medical
diagnosis.
|
|
|
|
©
2008 Osteometer MediTech, Inc.
All rights reserved. |
|
|
|
