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As a Senior Contributor to InCompliance Magazine, I have been fortunate to been asked to be part of this special supplement where InCompliance Magazine is featuring people that have been involved in Medical Device Compliance and Standards Development for a
On 2 Nov 2015 FDA issued a draft Guidance document titled: “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices”.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
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
Join Us at RAPS Regulatory Convergence Conference on Monday October 26, 2015 to Discuss Wearbale Devices Topic: “Wearable Devices: How to Make Them Safe and Adhere to Regulations” Presenters: Leo Eisner & Mary Weick-Brady of Eisner Safety Consultants and Bakul Patel of OC,
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