Eisner Safety Consultants

The new MHRA website home page is now live and you are being sent to the Home Page of the newly revamped site! The UK MHRA has updated their website to be much more functional and you can find a lot of information about the Directives (i.e. MDD, IVD, & AIMDD) related to the medical [...]

The following is provided thx to one of Eisner Safety Consultants Associates, Christine Ruther: The recast of the Restriction of Hazardous Substances (RoHS) Directive has been released as 2011/65/EU.  You can read the directive at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:EN:PDF.  With the exception of the items listed in Article 2.4, the RoHS Directive applies to all Electrical & Electronic [...]

This article is courtesy from BSI Healthcare eUpdate of 11-APR-2011.  We send out thanks to BSI for such an informative and critical article for the medical device and IVD industries selling product in Europe (EU). Medical device manufacturers should be aware that it is not only the medical devices directives that are currently being considered [...]

On 16 November 2010 this Interpretative Document was issued to explain what is considered Placing Medical Devices on the EU Market.  The document refers to all 3 medical device directives including the amendment 2007/47/EC.  The 3 medical device directives this applies to are Active Implantables Medical Devices 90/385/EEC, Medical Devices 93/42/EEC, and the InVitro Diagnostic [...]

Eisner Safety Consultants Proudly Announces Launch of New Website Eisner Safety Consultants; a leading name in providing regulatory, quality system, and product safety consulting for the medical, in-vitro diagnostic, and hi-tech industries; proudly announces the launch of its revamped and improved website. We have kept the website simple, attractive yet easier to navigate and user-friendly. [...]