Posts in CE Marking

סדנה מעשית בהבטחת איכות ורגולציה של מכשור רפואי

June 4th, 2015 Posted by 510(k), CE Marking, FDA, Risk Management, Software Lifecycle Management, Test Management 0 thoughts on “סדנה מעשית בהבטחת איכות ורגולציה של מכשור רפואי”

2015-06-04_12-31-49

2015-06-04_12-36-35

Do I need a full validation of QPack, or is Orcanos COC is enough?

November 11th, 2014 Posted by 21 CFR Part 11, 510(k), CE Marking, Notified Bodies, Pre Market Approval (PMA), QPack Validation 0 thoughts on “Do I need a full validation of QPack, or is Orcanos COC is enough?”

What is COC: Type Approval or Certificate of Conformity is granted to a product that meets a minimum set of regulatory, technical and safety requirements.

Orcanos provides this certification for its customers, but the question whether its instead of QPack validation, well, in some places it is enough, for example in Europe (CE), and in some places its not, such as in US, FDA, where the medical device manufacturer must do a full validation of any IT software he uses, based on the intended use.

You need to check with your regulatory consultant about it.

How does medical device classification really being set?

September 11th, 2013 Posted by 510(k), CE Marking, Pre Market Approval (PMA), Risk Management 0 thoughts on “How does medical device classification really being set?”

It is not feasible economically nor justifiable in practice to subject all medical devices to the most rigorous conformity assessment procedures available. A graduated system of control is more appropriate. In such a system, the level of control corresponds to the level of potential hazard inherent in the type of device concerned. A medical device classification system is therefore needed, in order to apply to medical devices an appropriate conformity assessment procedure.

The classification of medical devices is a ‘risk based’ system based on the vulnerability of the human body taking account of the potential risks associated with the devices. This approach allows the use of a set of criteria that can be combined in various ways in order to determine classification, e.g. duration of contact with the body, degree of invasiveness and local vs. systemic effect.

According to the ISO 62304 Section 4.3 it is being said:

Software safety classification shall be done in accordance to the following guidance:

a) The MANUFACTURER shall assign to each SOFTWARE SYSTEM a software safety class (A, B, or C) according to the possible effects on the patient, operator, or other people resulting from a HAZARD to which the SOFTWARE SYSTEM can contribute. The software safety classes shall initially be assigned based on severity as follows:

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

If the HAZARD could arise from a failure of the SOFTWARE SYSTEM to behave as specified, the
probability of such failure shall be assumed to be 100 percent. If the RISK of death or SERIOUS INJURY arising from a software failure is subsequently reduced to an acceptable level (as defined by ISO 14971) by a hardware RISK CONTROL measure, either by reducing the consequences of the failure or by reducing the probability of death or SERIOUS INJURY arising from that failure, the software safety classification may be reduced from C to B; and if the RISK of non-SERIOUS INJURY arising from a software failure is similarly reduced to an acceptable level by a hardware RISK CONTROL measure, the software safety classification may be reduced from B to A.

 

Where the Lines Blur

For more than 90% of products, classification is very clear. Still, certain products cause confusion, and what may seem like an ordinary device might be considered a medical device or a drug (or combination, such as a drug-eluting stent) depending on claims and how it is used.

In conclusion, the first regulatory step toward European device compliance is to determine whether your device is considered to be a device and, if so, what the classification will be for Europe. You simply cannot let this determination be based on the US classification of your device.

 

 

Why there is a change in the approach regarding labeling as RISK mitigation

July 24th, 2013 Posted by 510(k), CE Marking, FDA, IEC60601, ISO 14971, Recall, RISK Assessment, Risk Management 0 thoughts on “Why there is a change in the approach regarding labeling as RISK mitigation”

A recent recall on Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube: class 1 recall – mislabeled packaging – See more at: http://www.healthcarepackaging.com/trends-and-issues/regulatory/bryan-medical-tracoe-mini-30mm-tracheostomy-tube-class-1-recall/ has proven some of the justification regarding the change in approch when putting labeling as part of the RISK mitigation. In the above case in the RISK assessment we should expect to see that not just labeling should be used to differentiate between the different devices but also packaging and coloring could be a good way to use on the device. Such mistake in labeling could affect patient safety since an oversized tracheostomy tube may cause permanent injury to the trachea. This product may cause serious adverse health consequences, including death. When we come to RISK assessment and decide to use labels as mitigation we may want to consider mistakes in packaging and address such cases as well or even perform change by design to avoid use of the device on the wrong application.

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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