ECM Program Supports Entrepreneurial Innovation in the Medical Device Market

ECM Program Supports Entrepreneurial Innovation in the Medical Device Market   One of the most daunting challenges for startup entrepreneurs in the medical device industry is understanding the complex requirements to achieve regulatory compliance through the design, submission and post market stages.  Anyone who does not meet the strict and multifaceted regulatory requirements throughout a product’s […]

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ISO 13485:2016 – Less than 6 Months for Transition

Next March 2019, the transitional period for medical device companies to comply the new ISO 13485 standard will end. What are the differences between the EN ISO 13485:2012 and the ISO 13485:2016 standards? What are the new requirements? How to comply? The driver behind the new version of the ISO 13485 standard is the promotion […]

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