ISO 13485
Quality Management System
ISO 14971
Application of risk management
The foundation to develop
medical devices
Medical device product standards
IEC 60601-1
Medical electrical
equipment safety
IEC 61010-1
Electrical equipment
safety requirements
IEC 60601-2
Medical electrical equipment
particular requirements
Implementation
of Medical
Device Software
Requires
Process standard
Affects
Affects
Affects
ISO 62304 Software development life cycle Development and maintenance of a safe software system
Inspires
irreversible impairment or damage to a
body structure or function excluding trivial
impairment or damage.
It is relatively simple to apply a negative to the above to derive a nonserious
injury definition. However, the definition
of injury for use with the Class A software
safety classification may be debatable.
This is complex because of the lack of
definition of injury or damage to health.
For example, there may be a grey area
involving the normal side effects of treatment of a condition as opposed to the
device itself causing injury.
Procedures for carrying out this initial analysis and defining the class to be
applied have been developed. In some
cases, the notified body being used can
affect this decision. Some will recommend
that Class B is the minimum standard to
be applied for any medical product, as the
Class A safety classification does not insist
on a sufficiently rigorous software development process.
Medical & Diagnostic Devices
Primary Pharmaceutical
Packaging
Medisize expertise
We bring smart
solutions to life
As the leading contract design and manufacturing
partner for the healthcare market, Medisize, is a company driven by creative development and innovation.
Medisize built upon a reputation of proven expertise
in product design, in-house tooling, assembly and
manufacturing. Medisize is positioned like no other to
offer customized solutions.
We offer solutions in 4 business areas:
Drug Delivery Devices −
Primary Pharmaceutical Packaging −
Medical & Diagnostic Devices −
Airway Management −
Head Office Äyritie 8 B, 01510 Vantaa, Finland f +358 (0) 13 268 4000 f +358 (0) 9 562 91130 e info@medisize.com w www.medisize.com
emdt.co.uk European Medical Device Technology
June 2010 | 23
