Safety Risk Management for Medical Devices Process and Pitfalls

Keywords process and pitfalls risk management for medical devices safety risk
Standards groups

The devices must be designed and manufactured in such a
way that, when used under the conditions and for the
purposes intended, they will not compromise the clinical
condition or the safety of patients, or the safety and
health of users or, where applicable, other persons,
provided that any risks which may be associated with
their use constitute acceptable risks when weighed
against the benefits to the patient and are compatible
with a high level of protection of health and safety.

Date published
Document type
Defines standard
Replaced/Superseded by document(s)
Cancelled by
Amended by
File MIME type Size (KB) Language Download
2010-08-26 Presentation on SRM for Medical Process and Pittfalls.pdf application/pdf   3.27 MB English DOWNLOAD!
File attachments
Cover images

MEDRAD was founded in 1964, when "Doc" M. Stephen Heilman, M.D.
created the first flow-controlled, angiographic power injector in the kitchen of
his home.

MEDRAD later introduced injectors for computed tomography (CT) and
magnetic resonance (MR) imaging, and has become the leading provider of
ancillary devices for the MR suite.

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