Eisner Safety Consultants: Qmed Qualified Supplier

Global Medical Device Regulatory & Standards Updates

Enjoy our Second global standards & regulatory update.  It provides you with tools to help strategically plan for regulatory & standards updates for the Medical Device Industry Let’s start with some really big news!!! It is anticipated in 2019 IEC 60601-1 edition 3 + Amendment 2 will be published & around 2024 we anticipate that 4th ed. of […]

World-Wide Medical Device Regulatory & Standards Updates

Special global update post that gives you tools to help strategically plan for regulatory, & standards updates for the Medical Device Industry For this special posting I thought we should travel the world & provide you with a great deal of valuable information to help you on your product development way, including regulatory support, standards […]

FDA Draft Guidance – Info to Support a Claim of EMC for Medical Devices

On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”.  The Guidance was developed to describe the types of information that the FDA expects to be provided in a premarket submission to support a claim of Electromagnetic compatibility (EMC) for electrically-powered […]

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

This post discusses Health Canada’s most current List of Recognized Standards for Medical Devices effective 31 Aug 2015. Health Canada updated their list of Recognized Standards for Medical Devices on August 31, 2015.  The changes included additions, updates and removals to the listing.  Part of the update was adding the Canadian National Version of IEC 60601-1, edition 3.1 […]

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 […]