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March 24, 2011
The EU Medicinal Products GMP contains an Annex (11) on use of computerized systems. This annex identifies requirements for validation, electronic records, and use of third party software.  In some instances it is more specific than FDA requirements.  The new version at the link provided obsoletes the Dec 1998 version when it becomes effective June...
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This content is only available to our Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. Read the Swedish formal objection to the harmonization of ISO 13485. Sweden Formal Objection ISO13485 Medical Devices
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This content is only available to Standards Navigators subscribers.  See our Subscribe page for information on subscriptions. The Industry response to the Swedish objection to ISO 13485 can be found at the following link:   Industryresponseto13485objection I had previously posted regarding the Swedish objection at this link:  
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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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