Europe is the world's second-largest medical device market with 500 million people, 20+ languages, 32 countries and (fortunately) only one approval process. This short video gives you a high level overview of the CE Marking process in Europe as it exists currently under the Medical Devices Directive (93/42/EEC). We discuss how devices are regulated, classification of devices, the role of your EC REP, QMS requirements and more. Read more about our European CE compliance services or download this free chart on the medical device approval process in Europe.
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
read moreThe publication of ISO 13485:2016 introduced significant changes for device manufacturers around the world. Some changes are specific, while others
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