Dec

2016

IEC 82304-1: Health software Std Released

“IEC 82304-1: Health software – Part 1: General requirements for product safety” has been approved and released. It can be purchased from the ISO at the link provided. This standard addresses Health Software Products in general and does not attempt to define which are regulated and which are not. Its scope is all standalone software not intended to become part of specific hardware designed for its medical use. It refers to IEC 62304 in many places as a normative reference and separately mentions IEC 62366 for Usability. The primary focus of this standard is on requirements for the developers, installers and maintainers of the software product. It is intended to be used alongside IEC 62304 and to cover aspects of the software product that are not covered in IEC 62304, such as accompanying documentation and software validation.

ISO – IEC 82304-1:2016

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IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

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Being Agile & Yet Compliant (Public or Private)

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

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IEC 82304-1: Health software Std Released

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