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ESC New Annual Standard Reports Available by Early April ’16

Do you make Medical Electrical Equipment & Systems (MEE&S) or Home Use MEE&S? Are you up to date on all the applicable Current & Draft Medical Electrical Equipment Standards, Technical Reports, etc?

Do you have the resources to do this efficiently and with minimal cost & time?

  1. Are you able to have one or more employees from your company sit in all the standards developing meetings to write the standards?
  2. Can you afford the high fees of being on the National Committees?

If not, consider an Industry Leader’s specialized Annual Reports on Medical Electrical Equipment & Systems (MEE&S) Standards or on Home Use MEE&S StandardsLeo Eisner has over 20 years experience in the medical electrical equipment product safety industry with standards development as one of his primary focuses for over 12 years and he is on many of the standards committees that develop the standards in these reports both on the MEE&S and Home Use MEE&S markets.

What are the implications if you don’t stay up to date on these critical documents?

  1. You may need to redesign your product before submitting to a regulatory agency for review and approval,
  2. Your Notified Body Auditor or your Quality System Certifier may issue a Non-Conformance for not being up to date on the applicable standards and technical reports that apply to your products.
  3. Your regulatory strategy for your products lines may be out of date which could delay your products getting to market on time.
  4. And more….

If you’re a medical device company that makes any type of electrical equipment you will want one or both of these reports as there are a lot new standards, Technical Reports and related documents recently released and also being developed that you should be on top of. Many Medical Device Companies don’t have the resources (time & money) to afford to have someone sit in the standards meetings, commit to the time to support the committee work to write the standards, and pay the high fees needed to be a national committee member of ANSI, AAMI and other standards developing organizations. That’s why many in the medical device industry rely on Leo Eisner of Eisner Safety Consultants to provide them with detailed reports on what is happening with all these changes.

If you want to stay up with the currently and in process medical electrical equipment and system (MEE&S) standards and home use MEE&S standards and technical reports before they are published or while in development to help with their regulatory strategy it is always helpful to know what is coming up in the near to long term. Also, it is good to know what has been published too as new titles don’t always get into standard update services clients get from standards sales houses because those are not being monitored yet.

These reports are based on the Annual Standards Committee Meetings plus all Leo’s standard committee involvement.  Leo was at the Kobe meeting in Japan Nov 2015 and this report covers what are the future plans for many of those Standards & Technical Reports including:

1) IEC 60601 series of standards on Electrical Medical Equipment and Systems (status update on changes in process),

2) Draft IEC/TR 60601-4-2  Electromagnetic immunity Guidance & interpretations,

3) IEC/TR 60601-4-3 interpretations of IEC 60601-1, Ed. 3.0 & 3.1 (I am on this Working Group),

4) Draft IEC 62366-2 Guidance on the application of usability,

5) IEC/ISO /TR 80001-X-Y series on Application of risk management for IT-networks incorporating medical devices,

6) Draft IEC 82304-1, ed. 1.0 Health software – Part 1: General requirements for product safety,

7) IEC 62304, Ed. 2.0 – Software Lifecycle Process,

8) Draft IEC/TR 60601-4-1 Guidance and interpretation – Medical electrical equipment and medical electrical systems employing a degree of autonomy,

9) Draft IEC/TR 60601-4-4 Guidance for writers of particular standards on creating alarm system related requirements (Not even on the official IEC Work Program as of March 15, 2016 but being on these committees I get a birds eye view of what is going on and I have direct links with lots of the committees I am not directly on as well),

10) US Version of IEC 60601-1-11 on home healthcare environment for Medical Electrical Equipment and Systems,

11) Draft of US Version of IEC 60601-1-12 on Emergency medical services environment for Medical Electrical Equipment and Systems,

12) Draft AAMI TIR75, Factors to Consider When Multi-Vendor Devices Interact Via an Electronic Interface, (Proposed new Technical Information Report),

13) IEC 62366-1, Edition 1.0 Medical devices – Part 1: Application of usability engineering to medical devices, and how FDA is dealing with this and the older version of the standard,

14) etc…

Other area of Interest in the report include:

1) Some regulatory impacts of some of the standards in the report like what is FDA expecting on IEC 60601-1-2:2014 (4th ed vs 3rd ed)

2) Harmonization roadblock issues for the EN 60601 series and how best approach it.

This should give you a flavor of the reports.  I also provide listings of the TC62, SC62A & 62D (some 62B & 62C) Committees for Electrical Medical Devices for IEC & EN standards & technical reports that have been issued in the last year or so and drafts of EN standards close to publication (not Harmonized just EN).

For the Home Use Report I have 13 pages of information on the Committees that focus on Home Use for the US and also for IEC (new Systems Committee for Active Assisted Living) plus lot of additional information.

These reports will be ready for release by the end of March or early April 2016. Cost $3,500* (US$) per report or for both of them just $6,500** (US$).  This is steal compared the time I socked into each one of these reports, the meetings I sat in on for 2 weeks in Nov in Japan (Kobe & Tokyo) in Nov 2015, and also the money saved not having to be on the committees, the travel expenses for getting to the meetings,  the time in the meetings, and the expected contribution to the standards development for being in these committees.  That is a lot of man hours that you get inexpensively from my hard work.

Contact us to purchase a copy of these reports now. Leo at EisnerSafety dot com or call us at 503-244-6151.

* Current & past Eisner Safety Consultants Clients are eligible for a bigger discount if you purchase one of the reports.  To see the current discount go to the specialized services webpage for more details and for payment terms.  Please contact us to arrange for this special discount.

** Current & past Eisner Safety Consultants Clients are eligible for a bigger discount if you purchase both of the reports.  To see the current discount go to the specialized services webpage for more details and for payment terms.  Please contact us to arrange for this special discount.

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