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Month: January 2018

Obtaining Actionable FDA Feedback: How to Develop Targeted Questions for Pre-Submission Meetings

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Introduction Within any industry, if you ask poor questions, you will often get poor answers. This is especially true for the medical device industry and more specifically, for product manufacturers seeking feedback from the U.S. Food & Drug Administration (FDA). Simply put, asking better questions can assist device organizations to identify and solve potential device … Continued

ISO 13485:2016 – Effective Preparation and Implementation of Medical Device Quality Management Systems

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Introduction The International Organization of Standards (ISO) is a worldwide federation of member bodies within a specific technical skill set that is responsible for the draft and release of global medical device regulations. In 1996, the ISO established guidance ISO 13485:2003 under the jurisdiction of the ISO / International Electrotechnical Commission (IEC) Directive, Part 1 … Continued