Osteometer Meditech inc Bone Densitometers Quality

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 audited 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 its 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 21 CFR part 1020.30, GMP Regulations (21 CFR part 820) of the US Food and Drug Administration, CE Marking Requirements and in compliance with ISO-13485 Standard.

 

 

Standard
Description electrical equipment. Part 1: General requirements for safety
Osteometer Regulatory Compliance

IEC 60601-1

Medical electrical equipment. Part 1: General requirements for 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 60601-6/62366

Application of usability engineering of medical devices

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.

EN 62304

Medical Device software life cycle processes

93/42/EEC

Medical Device Directive annex II