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Update to BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s

BSI recently updated the white paper on Proposed EU Regulations for Medical Devices & IVD’s to reflect the latest EU vote in early April, enabling the commission to move forward with the legislation.

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BSI White Paper on Proposed EU Regulations for Medical Devices & IVD’s

This article focuses on BSI’s new White Paper Series for the Medical Devices & IVD’s industries, First one on the EU Proposed Regulations 9 April 2014 – Today marks the beginning of a series of white papers that BSI has just released.   White Paper on Proposed EU Regulations This initial white paper is on [...]

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RoHS 2 Directive (2011/65/EU) Changes to Annex IV (Med Dvcs & Control/Monitoring Instruments) Exemptions Listing

(Originally posted March 5, 2014 & updated March 6, 2014)  The changes made to these 16 Delegated Directives to the RoHS 2 Directive (2011/65/EU) add more exemptions to Annex IV of the Directive.  Annex IV is for the “Applications exempted from the restrictions in Article 4(a) specific to medical devices and monitoring and control instruments”. [...]

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EU Council Meets Tues 10 Dec Proposals for Med Dvc & IVD Regulations

medicaldeviceslegal.com comes through again with another fantastic post of  7 Dec 2013 by Erik Vollebregt of Axon Lawyers that is full of valuable information and is a good summary of where things stand and what is expected to happen when the EU Council meets to discuss the dossier of medical devices and IVDs revision (proposed [...]

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OSHA to Add AAMI ES 60601-1 to ‘List of Appropriate’ NRTL Program Test Standards

OSHA adding AAMI ES 60601-1 to the ‘List of Appropriate’ NRTL Program Test Standards is discussed in this blog. BIG News!!!  News, I have been waiting for many years now is that OSHA, finally, under it’s NRTL (Nationally Recognized Test Lab) program will be adding the US National version of the IEC 60601-1:05 + A1:12 [...]