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Events
Disclaimer: The events found at this site are provided solely as a service to our visitors. The listing of these events does not constitute an endorsement of these organizations or their programs by Eisner Safety Consultants, and none should be inferred. Eisner Safety Consultants is not responsible for the content of the Web pages found through these links.
Medical Device Industry Event Calendars click here.
Topic: “Implications of the Electro-medical Standards IEC 60601-1-11:2010 & Proposed IEC 60601-1-12” The Medical Electrical Device Collateral Standards in the Home Healthcare Environment and the Proposed Emergency Medical Services Environment, respectively
Presenter: Leo Eisner of Eisner Safety Consultants
When: March 3, 2011 (Thursday), 8:30 – 9:30AM (Pacific), 11:30AM – 12:30PM (Eastern)
Where: At your office or conference room (No travel required)
What’s it about: Get up to speed on the latest and developing requirements for the electro-medical collateral standards for the home healthcare environment (HHE) IEC 60601-1-11:2010 and the proposed IEC 60601-1-12 standard for the emergency medical environment (EMS). Is your company ready for the implications of these standards as you will have regulatory requirements for the HHE standard come up soon (depending on the country of concern) and it will be similar once the EMS standard is published.
In this audio conference, Leo Eisner guides you through IEC 60601-1-11:2010 with new definitions, additions and changes to the general standard. The presentation reviews the significant issues including earthing requirements and additional mechanical and environmental tests. It also compares the requirements of each standard to provide a perspective on what the EMS may look like vs. the HHE standard.
Cost & Registration: Fx Conferences registration page for this event. Cost is normally $249.00 but with the Eisner Safety Consultants special discount you pay only $199.00. When checking out use the $50.00 discount code AF2009EIS.
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If you missed any of Eisner Safety Consultants Presentations thru FX Conferences on IEC 60601-1, 3rd ed., the MDD Amendment 2007/47/EC and FDA 510(k)s you can purchase any of them now and get a $50.00 discount by using the Eisner Safety Consultants special discount code. When checking out use AF2009EIS for the coupon code. This discount is only applicable for these specific products:
- Is Your Product Development Cycle Ready for IEC 60601-1, 3rd Edition? (Mar 2010 Update)
- Are You Ready for MDD Amendment 2007/47/EC (Effective Mar 21, 2010 Update)
- How to Mark & Label Devices Under IEC 60601-1, 3rd edition
- Industry Update: Where Do We Stand With IEC 60601-1, 3rd edition (Feb 2009)
- Understanding the Principles and Pitfalls of 510(k) Submissions
Medical Device Industry Event Calendars
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FDA Workshops & Conferences
QMED Events Calendar (Previously Medical Device Link)
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Past Events (Info that still may be of interest to you)
Topic: “Make sense of the IEC 60601-1-11 standard” The Medical Electrical Device Collateral Standard in the Home Healthcare Environment
Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Joseph Murnane of Underwriters Laboratories
When: Feb 10, 2011 (Thursday)
Where: Anaheim Convention Center while you are at the MD&M West Conference
What’s it about: The market for home healthcare equipment is expected to grow exponentially over the coming years, as the delivery of healthcare services shifts from clinical settings to the home. But manufacturers face a series of unique challenges in supplying home healthcare equipment that is both effective and safe. IEC 60601-1-11 “Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in Home Care Applications” was recently published to address the safety hazards that exist when medical devices are moved into the home. IEC 60601-1-11 is a collateral standard, meaning that it directly references provisions in IEC 60601-1, and is used in conjunction with IEC 60601-1 for the certification of home healthcare equipment. In addition to the publication of the new standard, FDA has launched the Medical Device Home Use Initiative, which is expected to impact the regulatory approvals of medical devices for use in the home. In this presentation, two leading experts in medical device safety, one who participated in the writing of IEC 60601-1-11 and the other working on a sister standard for the emergency medical services type electrical medical devices, will discuss the major considerations all design engineers must consider whern designing a medical devices that may be marketed for home use.
Learn more: About DesignMed West 2011
Conference Registration: Webpage
Biomedical Division Northern California Discussion Group and
San Francisco Bay Area Chapter
Topic: ”Evolving Risk-Based Regulatory Requirements” whole day workshop covering 3 key quality & regulatory areas:
- IEC 60601-1, 3rd ed. general, collateral, and particular standards including essential performance, risk management integration, and the impact of change on industry
- Usability and Human Factors verification, validation, and regulatory requirements
- Clinical evaluation and investigation regulatory requirements
Presenters: Leo Eisner of Eisner Safety Consultants will be co-presenting with Geetha Rao, PhD, VP, risk management and strategy, Triple Ring Technologies, Inc; Ibim Tariah, technical director, BSI Healthcare; Craig J. Coombs, RAC, president, Coombs Medical Device Consulting, Inc.; and Juergen Stetin, president and CEO, PROSYSTEM AG
When: March 4, 2011 (Friday), presentations start right at 8:30AM check-in 7:45AM with Continental Breakfast
Registration Contact: Wesley Carr or call +1 301-770-2920 ext. 231 Registration form for event, must register by Feb 25, 2011, space is limited
Where: Crown Plaza Mid-Penisula, 1221 Chess Drive Foster City, CA 94404
