EU Data Protection Regulation

This regulation applies to all companies collecting and processing personal data in the EU and does include medical devices.  There is NO grandfathering under the GDPR, so in May 2018 all existing systems must be able to meet these requirements.   It specifically lists genetic data and biometric data as sensitive personal data.  Developers (both medical device and health products that are not regulated as medical devices that collect or process personal data) will be under specific obligations to introduce data protection by design and default into their systems.

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62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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