Leo Eisner has more than 20 years experience in the medical electrical equipment product safety industry, with more than 12 years of standards development as one of his primary focuses. He’s on many of the medical device standards committees that develop guidance for the medical electronics industry and home use electronics industry.
Based on his expertise, his company, Eisner Safety Consultants, developed critical reports to help the medical electronics industry.
Eisner says there are very good reasons to stay up to date on the documents. “Companies that don’t keep abreast of the standards might face having to undergo expensive redesigns, as well as being issued a non-conformance from their quality system certifier for not being up to date on applicable documents.” Such unpreparedness, says Eisner, can cause product development delays.
One of the main goals of the reports is to provide key insights into the standards’ developments before they’re published, while in development, and for recently issued new standards. “Many medical device companies don’t have the resources to afford to have someone sit in the standards meetings, travel expenses & time to the meetings, commit to the time to work with committees that write the standards, and pay the high fees to be a national committee member of ANSI, AAMI and other standards developing organizations.”
Eisner notes that access to such insight can give a company a leg up. “One of the big news items in the report will be updates of 3rd edition, plus Amendment 2, and the 4th edition of 60601-1. In future versions, our plans are to develop a report detailing what we believe will end up in the documents and what will be dropped out. It is pretty powerful stuff to know in advance. You can get a handle on a couple years or more in advance of other manufacturers, which can be very valuable.”
Medical electronics database
In addition to the reports, Eisner Safety has developed a Standards Reconnaissance Database as an ongoing service. A mini-demo is available at www.eisenrsafety.net/demo. Eisner will review the drafts of the medical electrical standards and advise timelines and some details for quality engineers to do strategic planning. A periodic report that details important changes to the standards and vital analysis is included.
This is a continually growing service, says Eisner. “Over the next couple of months, we’ll be adding information on National Regulatory guidance documents (i.e. U.S., Canada, EU, IMDRF, etc.), including some white papers that often serve as low level guidance or recommendations. They will be able to search easier than most of the regulator sites to find the document information. Then there are two more phases after that so the database will be even more powerful by the time we finish the last phase of it.”