Posts in Medical Device Directive 93/42/EEC

Closed System LOOP FDA Recommended CAPA Methodology

October 11th, 2015 Posted by 510(k), FDA, Medical Device Directive 93/42/EEC, Standards and Regulations 0 thoughts on “Closed System LOOP FDA Recommended CAPA Methodology”

In this paper we are going to examine the quality of the event management process, and in particular the CAPA, referred to as corrective and preventive action.
As we think about the quality management systems (QMS), and their different components, certainly quality event management is one of the most important.
Additionally, as we look at the quality event management system more specifically, we see that it may be broken up into primary components:
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Safety classification and level of concern

March 15th, 2011 Posted by FDA, Medical Device Directive 93/42/EEC 0 thoughts on “Safety classification and level of concern”

Software safety classification required by the CE (According to IEC 62304) is based on the product type. The classification is 1, 2a, 2b, 3 (major).

The FDA safety classification is called level of concern, and it talks about the potential harm to the patient/user. There is Class I, II, III.

There is a list of questions to ask in order to determine the safety classification, such as “Is the software part of a product with high risk”

The risk management is on system level and is not related to the level of concern

Medical Device Regulatories (USA/Europe)

February 23rd, 2011 Posted by 21 CFR Part 11, 21 CFR part 820, CE Marking, FDA, Medical Device Directive 93/42/EEC 0 thoughts on “Medical Device Regulatories (USA/Europe)”

FDA ( Food and Drug Administration)

Required in the United States, the regulations used are CFR 21 Part 11 (CFR=Code of Federal Regulations), Electronic Records and Electronic Signatures, and 21 CFR Part 820 Quality System Regulations  (QSR), outlines Current Good Manufacturing Practice CGMP regulations that govern the methods which must apply to the development of software that acts as a component of a medical device. Companies who comply with the PMA FDA regulations recieve the FDA Approval.

Companies who comply with the 510(k) clearance are 510(k) cleared, but not FDA Approved.

MDD – European Medical Device Directive 93/42/EEC

European standard for risk protection associated with the design, manufacturing and packaging of medical devices. Compliance with the requirements of the MDD is declared by placing the CE marking on the product, which supply the device with a comfofmity decleration

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