Posts in 510(k)

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:
Read More.

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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”



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 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.

Elcam Medical Mitigating The Approval Risk – By Placing their documents on Pre-Audit alert system that implemented the complete V&V Medical Device module

July 14th, 2013 Posted by 510(k), Company News, KPI, Software Lifecycle Management, Validation and Verification 0 thoughts on “Elcam Medical Mitigating The Approval Risk – By Placing their documents on Pre-Audit alert system that implemented the complete V&V Medical Device module”

Based 2,323 California biomedical companies research, here are the main 10 threats those companies has reported on

  • #1 – FDA regulatory / environment
  • #3 – R&D productivity
  • #7 – Intellectual property protections
  • #8 – Ability to demonstrate effectiveness
  • #9 – Product liability
  • #10 – Unprepared workforce

The unspoken rule is that at least 50% of the studies published even in top tier academic journals – Science, Nature, CellPNAS, etc… – can’t be repeated. More than that if there was a development behind those studies it was impossible to recreate the documentations requires utilizing their business potential.

According to the same research the following answers given to the question: Why did the company delay the research or development project? Were as follows:

  • 40.2% – Funding not available (Second Round)
  • 27.8% – Regulation (FDA, EPA, SEC)
  • 25.8% – Change in corporate priorities or strategy
  • 4.1% – layoffs
  • 7.2% – Other

Orcanos Implementing NPI (New Product Introduction) for one of the legacy Israeli Medical Device company Elcam Ltd. In this project the focus was on getting the project started on the correct regulatory path and have taken the initiative documents created by the R&D group into a preset system that control and governance the regulatory path selected by the organization. The overall idea was to define the development path in which the specific product shall be using and to match the perfect system that will control and governance each step in the development lifecycle. To achieve this goal we have selected QPack Medical™ system that accepted the validation documents and for each document the system created set of KPI (Key Performance Indicators) as well as KRI (Key Regulatory Indicators) that triggered QPack Medical alert system with Pre-Audit notifications.


Mitigating Audit-Submission Risks



For example:

The insertion of MRD documents during the Idea/Concept stage trggered the following alerts


  • Market Requirements missing coverage matrix
  • Market Requirements maturity based on functional test results
  • Market Requirements missing due date
  • Unapproved market requirements
  • Readiness for PDR review



  • Missing Market Requirement Document
  • Missing Market Requirement  Specifications
  • Market Requirements missing traceability to product requirements
  • Market Requirements missing validation procedures






FDA drafts mobile medical app regulations

July 28th, 2011 Posted by 510(k), FDA 0 thoughts on “FDA drafts mobile medical app regulations”

This morning the US Food and Drug Administration offered up a set of draft guidelines for how it might regulate certain mobile medical apps. While this set of guidelines was years in the making, it became clear a few months ago that the FDA would publish draft guidelines around this time….Read more

510(k) Clearance and PMA

February 23rd, 2011 Posted by 510(k), Pre Market Approval (PMA), Software Lifecycle Management 0 thoughts on “510(k) Clearance and PMA”

PMA = Pre Market Approval

Risk Classification

Class I: Simple devices with a minimal risk to the user. Most of these devices are exempt from FDA clearance or approval. Examples: crutches, elastic bandages, bedpans.

Class II: Moderate level of risk to the user. Almost all of these devices require a regulatory submission before they can be legally marketed. As a rule, class II devices require 510(k) submissions. Examples: administration sets, sutures, inflatable blood pressure cuffs.

Class III: These devices pose a serious level of risk to the user, mostly because they are implants or sustain life. All of these devices require a regulatory submission before they can be legally marketed. As a rule, class III devices require a PMA (Premarket Approval) submission. Examples: implantable pacemakers, blood vessel stents, breast implants.

510(k) Clearance
The purpose of a 510(k) submission is to demonstrate that a device is “substantially equivalent” to a predicate device. The 510(k) submitter compares and contrasts the subject and predicate devices, explaining why any differences between them should be acceptable. Manufacturers may also submit a 510(k) if they alter their device. Not all changes require a 510(k) submission. In general, changes to a device’s intended use, contraindications, or basic operation require a new 510(k) clearance. Changes to blood-contacting materials, sterilization method, or performance specifications may also require a new 510(k).

The FDA does not “approve” 510(k) submissions. It “clears” them.

Premarket Approval (PMA)

A PMA submission is used to demonstrate to the FDA that a new or modified device is safe and effective. This standard is higher than is required for 510(k) submissions. Human use data from a formal clinical study is almost always required in addition to laboratory studies.

PMA devices can be legally advertised as “PMA-approved” or “FDA-approved.”




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