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RAPS Online Course - Device Risk Management

  • 1.  RAPS Online Course - Device Risk Management

    Posted 30-Jul-2017 19:35
    ​Has anyone taken this course recently?

    http://www.raps.org/EventDetail.aspx?id=19151

    I was going to refer someone to it, but then I say that the course description refers to ISO 14971:2012, and that it's not clear how long the course runs (4-8 hours).

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------


  • 2.  RE: RAPS Online Course - Device Risk Management

    Posted 30-Jul-2017 22:11
    Since there is no ISO 14971:2012, I would be skeptical.

    If the course cannot get the standard right, I question the value of any other information.

    I'm teaching a two day course in medical device risk management for FDA News.in September. I also know that Ed Bills teaches a very good course for AAMI.


    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: RAPS Online Course - Device Risk Management

    Posted 31-Jul-2017 02:12
    My bad. It's EN 14971:2012, which is the same as ISO 14971:2007, right?

    Still puzzled about the 4-8 hours.

    I will google, but if you have a link to details on the course you are teaching, I'd be happy to pass the info along.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 4.  RE: RAPS Online Course - Device Risk Management

    Posted 31-Jul-2017 06:18

    Skepticism is high; there is no EN 14971:2012.

     

    ISO 14971:2007 is the international standard. It describes a complete and detailed process to help manage medical device risk. (Think harm to patients or users.)

     

    In the EU there is variant, EN ISO 14971:2012, that changes the international process to align with the directives. In fact, there are three variants, one for each of the applicable directives (MDD, AIMD, and IVDD). There is confusion over the changes and what they require a manufacturer to do.

     

    Because the EU variants are more restrictive, the EU version has become the de facto standard.

     

    I'm skeptical that if the course authors didn't cite the correct version of the standard, there would be issues with their description of the process steps.



    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 5.  RE: RAPS Online Course - Device Risk Management

    Posted 01-Aug-2017 04:37
    Dan's spot on 2012 version is euro-centric not because of any risk-theoretical review but a pedantic-legal review of the words written into law 30 years ago. (OK 1988, but I'm only a few months out).

    We frequently have to produce two different risk analyses for customers and I dread having to defend the difference in court!

    Another euro-nightmare inspired by lawyers playing device experts ... or maybe I am just biased.

    FYI when the EC threatened to de-harmonize ISO 14971 the TC was so shocked they organized a rapid (well in standards terms) review and forgot to ask the US to attend the meeting. Not surprisingly the US did not accept the 2012 version .... right move imho!

    Hope that helps, but yes its a mess!

    Neil

    ------------------------------
    Neil Armstrong FRAPS
    CEO
    MeddiQuest Limited
    Peterborough
    United Kingdom
    ------------------------------

    Original Message


  • 6.  RE: RAPS Online Course - Device Risk Management

    Posted 03-Aug-2017 11:49
    Neil, great comment. Totally agree with you on the pedantic-legal review, but not only that, it seems that parts of the Z-annexes were forced by people that have not spent a day developing, selling, or using medical devices and don't understand real-life practical considerations of making medical devices.
    For example, the deviation related to ALARP.  I would like to see someone develop a device without practical and economical considerations related to risk, and then finding someone that can afford it.


    FDA actually does not care which version of the standard you use (heard it directly form an FDA Compliance Officer recently). The normative section of the standard is unchanged between EN ISO and ISO version. Compliance with Z-annexes is not at odds with the normative section, so you don't have to maintain two separate risk files.

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    Michael Zagorski RAC
    Pittsburgh PA
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    Original Message


  • 7.  RE: RAPS Online Course - Device Risk Management

    Posted 31-Jul-2017 05:52
    ​What might this be?

    "EN ISO 14971:2012 - what does it mean for Manufacturers placing products on the European Market?"

    EN ISO 14971:2012 - What Manufacturers Need to Know | BSI America
    Bsigroup remove preview
    EN ISO 14971:2012 - What Manufacturers Need to Know | BSI America
    On 31 July 2012 EN ISO 14971:2012, Medical devices - Application of risk management to medical devices, replaced EN ISO 14971:2009 as the European harmonized standard. The 2009 version was considered obsolete as of the same date. The 2012 version allows the presumption of conformity to the applicable Essential Requirements of the three Medical Device Directives, 90/385/EEC, 93/42/EEC and 98/79/EC.
    View this on Bsigroup >

    Surely bsi wouldn't reference a non-existent standard (?)

    ------------------------------
    Jean Bigoney PHD, RAC
    Managing Member
    Nu Device Consulting LLC
    Murphy NC
    United States
    ------------------------------

    Original Message


  • 8.  RE: RAPS Online Course - Device Risk Management

    Posted 31-Jul-2017 06:27
    BSI cited the standard correctly, EN ISO 14971:2012.

    Common incorrect citations include ISO 14971:2012 and EN 14971:2012.

    The prefixes are important. For example:
    ISO 13485:2016 is an international quality management standard for medical devices

    EN ISO 13485:2016 is the EU variant that shows the differences between the international standard and the directives

    EN 13485:2001 covers "Thermometers for measuring the air and product temperature for the transport, storage and distribution of chilled, frozen, deep-frozen/quick-frozen food and ice cream - Tests, performance, suitability"


    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 9.  RE: RAPS Online Course - Device Risk Management

    Posted 01-Aug-2017 10:13

    It appears that this is the European version of the standard. 

    From the BSI website:

    What is the difference between EN ISO 14971:2012, EN ISO 14971:2009 and ISO 14971:2007?
    There has been no change to the Normative Text of the standard; the Normative Text contains the requirements and is the same in all three versions. Only the Annex Zs of EN ISO 14971 have changed in the 2012 version. The new Annex Zs describe where the EN ISO 14971 standard does and does not meet the requirements of the European Directives. The Annex Zs describe these differences as Content Deviations for each Directive.


    ------------------------------
    Susan Hamann RAC, FRAPS
    President
    Hamann QR Consulting
    Burlington MA
    USA
    ------------------------------

    Original Message


  • 10.  RE: RAPS Online Course - Device Risk Management

    Posted 31-Jul-2017 07:59
    Dan,

    They meant BS EN ISO 14971:2012. Think they just made a typo. 

    Ginger Cantor, MBA, RAC
    Centaur Consulting LLC centaurconsultingllc@gmail.com
    (715) 307-1850



    Original Message


  • 11.  RE: RAPS Online Course - Device Risk Management

    Posted 31-Jul-2017 08:24

    BS EN ISO 14971:2012 is a different standard. Notice the change in prefix. The content EN ISO 14971:2012.

     

    In the EU, CEN prepares these standards, but does not publish them. The national standards organizations publish them, adding a prefix. There are about 40 different standards organizations that publish a national version of EN ISO 14971:2012. For example, the UK version is BS EN ISO 14971:2012, the Republic of Moldova's version is SM SR EN ISO 14971:2012, the Former Yugoslav Republic of Macedonia publishes МКС EN ISO 14971:2012.

     

     

     

    As an additional note EN 14971:2006 is for "Textiles - Knitted fabrics - Determination of number of stitches per unit length and unit area"

     



    ------------------------------
    Dan O'Leary
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 12.  RE: RAPS Online Course - Device Risk Management

    Posted 31-Jul-2017 08:55
    Dan and Julie,

    Thanks for the recommendation Dan, I appreciate it, but there are a number of instructors at AAMI that are involved with the very popular program that is a classroom course 2-1/2 days long and is given in a public format and an on-site program.  I have been involved in a number of sessions of both formats this year.  

    As for the RAPS course, I was one of the original authors and participated in revising it twice, the last time in  2015.  Not sure if it has been revised since then.  It consisted of 5 lessons which when printed covered about 101 pages including the exam, according to my files.  It was updated to include ISO TR 24971 and EN ISO 14971.  

    I am not sure where you found the ISO 14971:2012 reference Julie, but my last contact with the course had the proper reference.  I think it was a good entry-level course, but there is more to learn about medical device risk management than the on-line course can provide.  It should give a good grounding on terms and available reference material.  

    All risk management systems including Enterprise Risk Management, Pharma Quality System Risk Management (ICH Q9), and Device Risk Management, are important in today's regulatory environment due to changes in standards (ISO 14971 and the EN version), the recent release of ISO 13485, and the new EU MDR (which includes risk management), as well as upcoming changes to SIO 31000 Enterprise Risk Management.  Additionally, companies are moving into combination products which may require an implementation of both ICH Q9 and ISO 14971 for the product risk management side, and ISO 31000 for regulatory compliance, financial and project risk, for example.  Thus risk management is not a simple topic.  I have been involved with medical device risk management and pharmaceutical quality risk management for over 20 years and find I am learning something new every day.

    Good luck, Julie.  If you want an introduction to this complex topic try the course.

    ------------------------------
    Edwin Bills RAC, MA
    Principal Consultant
    ELB Consulting
    Overland Park KS
    United States
    ------------------------------

    Original Message


  • 13.  RE: RAPS Online Course - Device Risk Management

    Posted 31-Jul-2017 09:12
    ​Thanks, Edwin.  Can you explain the 4-8 hours for the RAPS course? 

    On the AAMI course, the only one I found on risk management was "Integrating Risk Management Into the Quality System."  It sounds like a good course, but I was searching for a course for someone who is looking for training specifically in the standard.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 14.  RE: RAPS Online Course - Device Risk Management

    Posted 31-Jul-2017 09:38
    This is another course on Risk Management put on by Qmed in 2017.  It is 3 hours and no cost:

    Risk Management for Medical Device Manufacturers | Qmed

    "The three day course – on Risk management is an important and challenging topic for all medical device manufacturers. But what is risk and how do we manage it? There are many connotations of risk and many methods used to manage them. Although there are "industry standards" such as ISO14971 and others, risk remains a source of confusion for manufacturers and regulators alike. During this 3-part interactive webinar, a more systematic, engineering-minded approach to risk is presented using multiple examples of medical devices to demonstrate important concepts. Ultimately risk is not a simple matter! Following the webinar, participants will have a much better appreciation of the importance of risk and how to manage it."

    ------------------------------
    Alyssa Roelli
    Senior Quality & Regulatory Engineer
    Diversatek, Inc.
    Milwaukee WI
    United States
    ------------------------------

    Original Message


  • 15.  RE: RAPS Online Course - Device Risk Management

    Posted 01-Aug-2017 08:31
    Julie,

    The AAMI course title you found is the correct course. It covers the ISO 14971:2007 course as recognized by FDA. The course approaches risk management by breaking it into segments that can be integrated into the quality system as required in ISO 14971:2007. It is broken down by segments such as Design Input, Design Output, etc.

    As for the RAPS course it was long enough ago that I last touched it, that I can't tell you about the hours. I did look at the last revision we did (the course was created and revised by a group of experts, not just me, I should have explained earlier) before responding. As I said the printed version I had was 100+ pages and included exams and a great list of references for further study. It does include the ISO TR 24971 guidance which most people do not know about, and is a great source of "how to" information on implementation of ISO 14971:2007. This is an essential document for those responsible for a company's risk management system.

    I might mention that the current path we (the ISO TC revising ISO 14971) are following. The standard will most likely have the informative annexes, with the exception of the rationale in Annex A, moved to ISO TR 24971 (or with a new number, ISO 14971-1 or similar numbering) and updated to include new information all in one document. We currently expect to have a revised standard (and guidance) in the fall of 2019, if all goes well. CEN in Europe will have to create a new revision of EN ISO 14971 and could do it in parallel with ISO as has been done with other standards, so the EN ISO 14971:2012 will be withdrawn and replaced with a new revision.

    Ed Bills
    843-810-2157
    Sent from my iPhone


    Original Message


  • 16.  RE: RAPS Online Course - Device Risk Management

    Posted 02-Aug-2017 15:53
    ​Hi Julie,

    It looks like you have an unanswered question about why it is 4-8 hours. It is an online "self-paced" course that is worth 4 RAC credits, representing 4 hours. I think they just mean expect it to take 4 to 8 hours when working at your own pace.

    Best regards,
    Kevin

    ------------------------------
    Kevin Hawkins, RAC
    Director, Quality & Regulatory Affairs
    Portland OR
    ------------------------------

    Original Message


  • 17.  RE: RAPS Online Course - Device Risk Management

    Posted 02-Aug-2017 08:39
    Hi All, 
    I took this course from RAPS about a year ago as part of Medical Device Certificate program (which is not the same as a RAC).  The course is on EN ISO 14971:2012.  It is an on-line course and takes approximately 3-4 hours to view the entire slide deck and presentation.  There is a test at the end.  It can take up to 8 hours (or more) to complete the course based on the following:  a) you are slow reader - which I am when it comes to gaining a complete understanding of technical material, b) new to the information and pause or rewind the course for understanding, c) take time to look at the additional suggested materials.  

    The course is presented as an introductory level to the standard.  I have been working in the medical device industry for many years and am very familiar with the standard so I was able to complete the course in around 4 hours.  If I was being exposed to it for the first time I think I could have easily spent 8 or more hours trying to comprehend the the material so that I would pass the test at the end.  

    I hope this is helpful.

    ------------------------------
    Sara Coon RAC
    Assoc. Director, RA
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 18.  RE: RAPS Online Course - Device Risk Management

    This message was posted by a user wishing to remain anonymous
    Posted 03-Aug-2017 15:48
    This message was posted by a user wishing to remain anonymous

    Hi Sara,
    Would you recommend it?
    Original Message


  • 19.  RE: RAPS Online Course - Device Risk Management

    Posted 07-Aug-2017 08:22
    Anonymous asked if I would recommend the on-line course.  T depends on what you are looking for.  If you are looking to learn the basics of the standards and get a general understanding of risk management or get a refresher in the standard after several years of being "out of the loop",  I would recommend it.  If you are familiar with the Risk Management Process and are looking for more in-depth understanding of the process possibly for applications to complex products, it may not be as valuable.  
    I hope that helps.
    Sara

    ------------------------------
    Sara Coon RAC
    Victoria MN
    United States
    ------------------------------

    Original Message


  • 20.  RE: RAPS Online Course - Device Risk Management

    Posted 04-Aug-2017 01:12
    ​Thanks for all of the additional information. 

    I also found the discussions of the different versions to be very interesting.  I think I'll just keep calling it "14971." :)

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


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