What is FMEA Technic for Risk Management

March 15th, 2011 Posted by ISO 14971, Risk Management 0 thoughts on “What is FMEA Technic for Risk Management”

FMEA – Failure Mode and Effect Analysis


A methodology to identify, quantify, prioritize and evaluate potential failure mode


Failure mode: What could go wrong

Effect analysis: How would it happen, how likely is it to go wrong, how bad would that be


  1. Reduce risk of failure
  2. Ensure failures are detectible
  3. Prevent failure from happening.

Prevention: A way to figure out what can go wrong and what can be done in order to avoid it


Ahead of time or during the project lifecycle when a potential risk is discovered

We do FMEA for procedures that can be risky or costly


Preventing problem is cheaper than cleaning it

Some things are too risky or costly to incur mistakes


Gather all relevant participants from several verticals to give their insight of potential risks

  1. Analyze risks
  2. Define the most critical and include them in the control plan

Define potential failure mode for each Process (can have several failure modes)

  • Cause of failure (Root cause) – what might cause this failure mode
  • Effect of failure (Impact of failure)
  • Current control – what is done today in order to prevent the failure
  • Hazard Score (RPN=Risk Priority Number, is the product of Severity, Occurrence, and detection rating)
    • Occurrence/Probability (how likely to occur) [F]
    • Detection [D]
    • Severity [S]
  • Prevention/Mitigation/Control (recommended actions)
  • Revised RPN – after hazard mitigation

IEC 62304 main processes

March 9th, 2011 Posted by IEC 62304 0 thoughts on “IEC 62304 main processes”

IEC 62304 addresses the following main processes:

  • Software development plan
  • Software development
  • Software requirements analysis
  • Software architectural design
  • Software detailed design
  • Software unit implementation and verification
  • Software integration and integration testing
  • Software system testing
  • Software release
  • Software maintenance
  • Software risk management (refers to ISO 14971)
  • Software configuration management
  • Software problem resolution

Time consuming activities in medical device documents management

March 9th, 2011 Posted by Software Lifecycle Management 0 thoughts on “Time consuming activities in medical device documents management”

Following are activities that consume most of the time in maintenance and preparation of the documents for submission:

  1. Manual Signatures
  2. Traceability maintenance
  3. Document audit trail
  4. Manual management of changes and comments

I will discuss each on my next posts

The challenge of 510(k) De Novo submission decision

March 8th, 2011 Posted by Software Lifecycle Management 0 thoughts on “The challenge of 510(k) De Novo submission decision”

There is a real challenge for a medical device company whether to go for 510 (k) De Novo submission.

First – lets understand some facts :

  • For some historical reason – there is a dependency between risk level (Class I, II and III) and submission required  (510(k)/PMA)
  • For risk level of class I and II – the medical device company is required to be 510(k) cleared
  • For risk level of class III – a PMA submission is required

But what is the case when the product is not based on exisitng product and the risk level is not Class III?

If the company succeeds to prove this claim – a 510(k) De Novo submission is allowed

This submission process expose the comapnies to competition. Once the company is 510(k) De Novo cleared – it means that their product is an existing product…. now the competitors can create a competitive product and submit the 510(k) based on the “existing” company product. Another issue is the efforts need to be invested in order to convince the FDA that the risk level is not class III.

and finally – there is a risk in the exposure of the company IP by the FDA during the risk level re- evaluation process.

Due to these reasons the medical device company sometimes choose to go for the PMA.

What standards are required for medical device software?

March 2nd, 2011 Posted by 21 CFR part 820, IEC 62304, ISO 13485, ISO 14971 0 thoughts on “What standards are required for medical device software?”

There are lots of standards, and I sometimes find it confusig, where people dont really know what is the acceptable standard for software lifecycle in medical device, acceptable by the FDA and CE. Some vendors also claim t support specific standards, such as 21CFR 820, which has nothing to do with softwaare lifecycle in specific.

I came to the final conclusion:

The acceptable standard for software lifecycle management is IEC 62304, you can find some data about it in this blog

The ISO 14971 talks about risk management

The 21 CFR part 820 is more or lessthe same as ISO 13485 and they don’t talk about software lifecycle in particular (see this link for reference: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820 ). The software lifecycle is only one part.

The FDA guidelines for software lifecycle managemnt are specified in the General Principles of Software Validation, and they are very hard to understand. Thats why it is recommended to use the IEC 62304 guidelines.

Quality Management System (QMS)

March 2nd, 2011 Posted by Software Lifecycle Management 0 thoughts on “Quality Management System (QMS)”

A quality management system (QMS) is the organizational structure, processes, data management, product quality procedures and resources needed to implement for quality management.

ISO 13485 For Medical Device

March 2nd, 2011 Posted by ISO 13485, Software Lifecycle Management 0 thoughts on “ISO 13485 For Medical Device”

SO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Source: http://www.iso.org/iso/catalogue_detail?csnumber=36786

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.”

Source: http://www.devicewatch.org/reg/reg.shtml

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

ISO 14971 For Medical Device Risk Management

February 23rd, 2011 Posted by ISO 14971, Standards and Regulations 0 thoughts on “ISO 14971 For Medical Device Risk Management”

ISO 14971 represents the requirements for a medical device risk management system.

This standard establishes the requirements for risk management to determine the safety of a medical device by the manufacturer during the product life cycle. Such activity is required by higher level regulation and other quality standards such as ISO 13485.

ISO 9000 Quality Standards

  • ISO 9001:  Design and Manufacturing
  • ISO 9002:   Manufacturing Only
  • ISO 9003:  Inspection and Testing Only

Page 15 of 16
1 13 14 15 16


8Beit Oved Street
Tel Aviv, Israel

Copyright © Orcanos, All rights reserved. | Privacy policy | Terms of use