Ready or Not: How Medical Device Manufacturers Can Prepare for EU MDR

By Medical Design & Outsourcing, September 2018

Best Practices for EU MDR Compliance

By mid-2020, medical device manufacturers selling products in Europe must comply with the significant regulatory changes embodied in the European Union Medical Device Regulation (EU MDR), or lose their ability to sell in the EU.

Two years might seem like plenty of lead time to ensure compliance, but time may actually be the most challenging aspect of the transition to the new requirements. To fully understand the EU MDR, this process can prompt new challenges and will be incredibly time consuming – but it can be done with a strategic approach.

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