QPack Medical Workshop For SMB

October 24th, 2011 Posted by Software Lifecycle Management 0 thoughts on “QPack Medical Workshop For SMB”

Orcanos has vast experience in escorting small-medium medical device manufacturers and 3rd party suppliers and assist in their development lifecycle management, including document generation to FDA/CE.

After QPack implementation, your organization will have the ability to manage the complete development lifecycle over QPack single repository, according to IEC 62304 and ISO 14971

–          You will be able to track and manage risk according to ISO 14971 (see GivenImaging risk management best practice: Risk Management Best Practice )

–          Requirements Management (Market, Product, Software, Hardware, Mechanic)

–          Test plan and execution including defect tracking

–          Change management

–          Document generation from QPack

–          Full traceability (System requirements->Software requirements, Software requirements->risk (mitigation), test case->Software requirement, etc…)

–          QPack validation

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

FDA to Medical Device Industry: Slow 510(k) Process is Your Fault

July 26th, 2011 Posted by Software Lifecycle Management 0 thoughts on “FDA to Medical Device Industry: Slow 510(k) Process is Your Fault”

Interesting article: http://blog.assurx.com/2011/07/22/fda-to-medical-device-industry-slow-510k-process-is-your-fault/

Risk mitigation safety control types

July 20th, 2011 Posted by ISO 14971, Risk Management, Software Lifecycle Management 0 thoughts on “Risk mitigation safety control types”
  • Change in design
  • Change in process – Protective measures (in medical device itself or manufacturing process)
  • Information (such as labeling, user manual)
  • Standards and compliance

IEC 60601-1 3rd Edition Requires Risk Management

July 18th, 2011 Posted by ISO 14971, Risk Management 0 thoughts on “IEC 60601-1 3rd Edition Requires Risk Management”
IEC 60601-1 3rd Edition Mandatory Adoption Dates:
– Europe: June 1, 2012
– Canada: June 1, 2012
– USA: July 1, 2013
IEC 60601-1 3rd Edition requires Risk Management process in accordance to ISO 14971
Please note clause 4.2 of the IEC 60601-1 3rd Edition that states:
“A risk management process complying with ISO 14971 shall be performed”.

Severity and detectable control in risk management

July 15th, 2011 Posted by ISO 14971, Risk Management 0 thoughts on “Severity and detectable control in risk management”

A dispute we encounter in many organizations.

Can the risk mitigation reduce the severity, or just the probability?

Another issue:

RPN is calculated by Severity * Probability

In some cases, companies use Detectable with is another factor used to calculate the RPN.

Is it relevant just in software risk management?

We will be happy to hear your input

Can we link test case to hazard for mitigation?

June 28th, 2011 Posted by ISO 14971, Risk Management, Test Management 0 thoughts on “Can we link test case to hazard for mitigation?”

In some occasions, test case is traced to a risk in order to assure mitigation. I believe this traceability used for risk mitigation is wrong.

The correct flow is adding a risk control, and then add traceability from the test case to the risk control (can be software requirement, user manual reference, etc.)

The test case will be used to verify that the control implemented is actually reduce the risk

So the test case is used for verification of the risk control and NOT as risk mitigation.

Software Validation and Verification

June 22nd, 2011 Posted by Validation and Verification 0 thoughts on “Software Validation and Verification”

Software Verification

The Goal is to provide objective evidence that the software meets all the specified requirements

> building the thing right

Software Validation

The Goal is to confirm that the software meets the user needs and intended uses

> building the right thing

Manage risk mitigation types

April 13th, 2011 Posted by Software Lifecycle Management 0 thoughts on “Manage risk mitigation types”

You can add custom field “Required Mitigation” in order to indicate which mitigations are required for a specific risk:

Risk mitigation types

Click to enlarge

Risk and software requirements traceability

April 12th, 2011 Posted by ISO 14971, Risk Management 0 thoughts on “Risk and software requirements traceability”

I have encountered the following question more than once:

Do we manage traceability from risk to software requirement (saying: this risk is derived from the linked software requirement) or do we link software requirement to risk (saying: this software requireemnt is used as risk control (mitigation) for the linked risk)?

The regulation requires management of the following traceability: Software requirement -> risk

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