Eisner Safety Consultants: Qmed Qualified Supplier

EU MDR & IVDR – Final Versions – Are You Ready (Updated 7, 12, & 17 March ’17)

Since our original post (below) we have made 3 additional updates to provide you with a lot more info and resources.  Check out our updates in this LinkedIn Article. Updates are all underlined: Mar 7, ’17 updates: * addition of the EU Council vote & date of release of final text * an important change that manufacturers […]

EU MDR & IVDR – Final Versions – Are You Ready, Transition Period Starts Soon

Final texts of the EU MDR & IVDR (R = Regulation) have been released recently and start their transition periods sometime in the early to mid 2nd quarter of 2017. The MDD has a 3 year transition period and the IVDR has a 5 year transition period.  You should be starting your quality planning now if you […]

Tips for Success When It Comes to IEC 60601-1 – Podcast

Jon Speer, founder and VP of QA/RA @ greenlight.guru and I, Leo Eisner, Principal Consultant of Eisner Safety Consultants, had a dynamic & interesting conversation that we are sharing as a podcast with you on tips for success when it comes to IEC 60601-1. Eisner Safety Consultants has teamed up with greenlight.guru, a specialized electronic Quality Management System […]

Standards Reconnaissance Service Coming Mid Oct ‘15 to Eisner Safety Consultants

Do you want to ensure standards compliance to meet quality & regulatory requirements? Compliance to standards has become a key part of regulatory requirements. Due to move towards Global Harmonization of regulations, it has become important not only for the developed markets of US, EU, etc. but also the emerging markets (e.g. China, Brazil, etc.) Our […]

Standards Reconnaissance Subscription Service Coming Soon

Does your Medical Device Regulator or your Quality System require that you maintain a list of applicable standards to meet these requirements for your product lines?  How much time does it take to put this list together and how much effort does it take to keep the list updated? If this is a struggle for […]