3. Medical device means any instrument, apparatus, appliance,
software, material or other article, whether used alone or in
combination, including the software intended by its manufacturer
to be used specifically for diagnostic and/or therapeutic purposes
and necessary for its proper application, intended by the
manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of
disease,
— diagnosis, monitoring, treatment, alleviation of or compensation
for an injury or handicap,
— investigation, replacement or modification of the anatomy or of
a physiological process,
— control of conception,
- MDD 93/42/EEC
“
6. Classification of
Medical Devices
Device Directives
Medical Devices (MDD)
93/42/EEC
In Vitro Diagnostic
Medical Devices (IVDMD)
98/79/EC
Active Implantable
Medical Devices (AIMDD)
90/385/EEC
11. Is SOFTWARE
a medical device?
Software intended by the manufacturer to be
used for one or more medical purposes (as
defined as a medical device), is a medical
device.
Standalone software for general purposes
when used in a healthcare setting is not a
medical device.
12. Classification of
Medical Software
Class A: No injury or damage to health is possible
Class B: Non-SERIOUS INJURY is possible
Class C: Death or SERIOUS INJURY is possible
- IEC 62304
17. Product testing
ISO 10993
Biological evaluation of medical devices
IEC 60601
Medical electrical equipment and systems
IEC 62304
Medical device software - Software life cycle processes
And other specific requirements…
20. Manufacturing Standards:
Quality Management Systems
GMP
ISO 13485
Medical devices - Quality management systems
ISO 14971
Medical devices - Application of risk management to medical
devices