|
Osteoporosis
is a disease that gives women a risk of 30-40% of having
an osteoporotic fracture in their lifetime. The lifetime
risk for men is approximately 13%.*
Osteometer MediTech's focus is on offering affordable,
high quality office based scanners and densitometers
for diagnosis of osteoporosis. Since the first densitometer
left the factory more than ten years ago, several thousand
densitometers have followed, and today Osteometer MediTech
is the market leader in office based densitometry in
several countries around the globe.
Quality and reliability are key elements for Osteometer
MediTech. From development to manufacturing, Osteometer
MediTech complies with the following standards:
IEC 60601-1-2 Medical Electrical Equipment (General requirements
for safety)
The Medical Device Directive (93/42/EEC)
ISO 13485: 2003 (E)
Furthermore, Osteometer's products are in compliance
with the Food, Drug and Cosmetic Act (FDA), CFR Part 21,
Title 820 (GMP).
Being one of the main market players within diagnosis
of osteoporosis, Osteometer MediTech is committed to
developing scientifically and clinically validated devices.
This has resulted in accurate, precise, reliable and
cost-effective scanners, making the diagnostic test
accessible to as many patients as possible.
|