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Health Canada Revised Significant Change Interpretation …

WebOn January 20, 2011 Health Canada issued a notice in regard to the “Guidance for the Interpretation of Significant Change of a Medical Device”.. This newly …

Actived: 5 days ago

URL: https://eisnersafety.com/2011/01/29/health-canada-revised-significant-change-interpretation-guidance-doc/

Root Cause vs “Systemic” Root Cause – Eisner Safety Consultants

WebThe “specific root cause” is loose connections—resulting in leakage of the refrigerant. Thawing the system and recharging it are corrections, while tightening the …

Category:  Health Go Health

IEC 60601-1, 4th Edition Project – Where Do We Stand

WebSome History. The “Architectural Specification for Safety Standards of Medical Electrical Equipment, Medical Electrical Systems, and Software Used in …

Category:  Medical Go Health

IEC 60601 Medical Electrical Equipment Classifications: FAQ’s

WebIEC 60601 medical electrical equipment classification frequently asked questions are discussed in this blog. Why do I need to classify my product for IEC 60601 …

Category:  Medical Go Health

IEC 60601-1 Amendment 2 Just Released

WebStandards: Explosion and Challenges Maintaining/Updating April 18, 2024; Stop Waiting to Join New WGs for IEC 60601-1, 4th ed. January 14, 2024

Category:  Health Go Health

Attention ISO 15223-1 4th Edition is Almost Here: How to …

WebContact Leo Eisner: [email protected] +1 503-709-8328 www.eisnersafety.com Pg 2 of 18 Attention ISO 15223-1 4th Edition is Almost Here: How to Update Your Medical …

Category:  Medical Go Health

Health Canada’s Guidance – Transition fr 2nd to 3rd ed. of IEC …

WebToday (22 MARCH 2012) Health Canada (HC) has issued to manufacturer’s of record (those mfr’s with a HC License to sell & market product in Canada) a NOTICE …

Category:  Health Go Health

IEC 60601-1:2012 Consolidated 3.1 Edition Just Published

WebOn August 20, 2012 IEC released the consolidated edition 3.1 of IEC 60601-1:2012 which is a combination of IEC 60601-1:2005 (also known as 3rd ed. of IEC 60601-1) combined …

Category:  Health Go Health

CAN/CSA C22.2 No. 60601-1:14 Added to Health Canada’s List of

WebThis post discusses Health Canada’s most current List of Recognized Standards for Medical Devices effective 31 Aug 2015. Health Canada updated their list …

Category:  Medical Go Health

IEC 60601-1-12 Just Published

WebYou can purchase IEC 60601-1-12 currently on the IEC website and in the near future I would expect it to be on the standards websites like TechStreet, IHS Global, the …

Category:  Health Go Health

Welcome Mary Weick-Brady to Eisner Safety Consultants

Webor call Leo at +1-(503)-244-6151. Leo is the Principal Consultant of Eisner Safety Consultants (bit.ly/EisnerSafetyConsultants).

Category:  Health Go Health

IEC 60601-1 Definition of Patient Applied Parts – Part 1 of 2

WebThis blog will you understand the definition of Patient Applied Parts for medical electrical equipment under the IEC 60601-1 Standard. This blog discusses the …

Category:  Medical Go Health

CAN/CSA C22.2 No. 60601-1:14 (Harmonized with Ed. 3.1) …

WebAs of March 1, 2014 Canada is now accepting edition 3.1 with National Deviations under CAN/CSA C22.2 No. 60601-1:14. I have been advised by CSA and a …

Category:  Health Go Health

MEDDEV 2.12-1 Guidelines on Medical Devices Vigilance System …

WebThis blog post is thx to our associate Christine Ruther and a special thx goes out to Helene Spencer. MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance …

Category:  Medical Go Health

Pre-release of IEC 60601-2-52 1st ed + Amendment 1 – Medical …

WebThis post is the early release of IEC 60601-2-52, 1st ed. + Amendment 1 (A1) before being issued as an International Standard (IS). It is currently available as an FDIS …

Category:  Health Go Health

Med Dvcs E-Lableing: Health Canada TPD’s Interpretation

WebOn November 9, 2010 Health Canada’s Therapeutic Product Directorate (TPD) issued an interpretation of the Medical Devices Regulations (Regulations) with …

Category:  Medical Go Health

BSI White Paper on Generating Clinical Evaluation Reports

WebUsability engineering. You can sign-up for the whole series of white papers too (further down the webpage on BSI’s website). If you need help with your EU CE Mark …

Category:  Health Go Health

IEC 60601-1-9 required for Brazil Near End of 2016

WebIf you need help with IEC 60601-1, any in the Series of Standards or any National Version of these standards please email Leo Eisner at …

Category:  Health Go Health

U.S. Food & Drug Administration 10903 New Hampshire …

WebU.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

Category:  Food Go Health

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