2- Day Training for RA/QA Professionals of the MD Industry
Software Lifecycle (EN 62304)
TBD | May 19-20, 2020 | Register Now!
About the training
The standard EN 62304 defines requirements for the life cycle of the development of medical software and for software within medical devices. It applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device.
As software testing cannot prove the correctness of software, software errors (bugs, usability problems) have to be avoided right from the beginning by following software life cycle processes. Software related regulations such as EN 62304 demand from medical device manufacturers to follow these life cycle processes.
The purpose of this course is to provide a clear understanding of how to effectively and efficiently integrate EN 62304 compliance into their software development lifecycle (SDLC).
GMED North America has created a 2-day training session, to equip medical device manufacturers with the right understanding and implementation of the Software Lifecycle (EN 62304) standard.
During this 2- day course, you will learn:
- Amendment 1 changes to 62304 (changes to risk and dealing with legacy software)
- Agile methods for medical device and Health IT software – while remaining compliant!
- EN 62304 integration Software Risk Management guidance from 80002-1
- EN 62304 Software Safety Classifications to prioritize rigor and documentation
- IEC 82304 for Health IT and standalone software and how 62304 training complements
- Cybersecurity planning, evaluation, and validation
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Keywords: European Medical Devices Regulation 2017/745, Quality Management System (QMS) , Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Electrical Safety (IEC 60601-1), Medical Device Electrical Safety, ISO 14971:2007, IEC 62366-1:2015), MDSAP, Medical Device Audit, Medical Device Single Audit Program (MDSAP), EN 62304, Software Lifecycle
WHO SHOULD ATTEND
- Medical Device Manufacturers: Senior Management, Regulatory Affairs Managers and Quality Managers, R& D specialists, Development, Manufacturing and Marketing Managers,
- Internal and external Auditors
- General knowledge of EN 62304
The number of participants is maximized to fifteen to provide a stimulating and practical working environment.
- Practical working sessions
- Course evaluation
- Lunch meeting with the trainer (Lead Auditor and Technical File Assessor for high risk devices)
- Knowledge of the European regulatory requirements (Medical Directive 2007/47 / EEC) and US (FDA) related to the development and software validation.
- Identify and understand normative documents or useful guides to claim conformance to regulatory requirements.
- Know how to implement the quality management principles for the development of software medical devices.
- Understanding and applying software risk management expectations from 62304
DAY 1 & 2
8:30 am to 9:00 am – Breakfast
9:00 am – 12:15 pm
- Welcome and Introductions
- The Regulation: the regulatory provisions relating to the development and software validation
- Introduction to the US and European requirements
- Introduction to standards and guides available to industry to address regulatory requirements
- Planning software development
- Defining Requirements (System Input Data)
- Building & Design of software
12:15 pm - 1:00 pm - Lunch
1:00 pm- 5:30 pm
- Implementation of a risk management process applied to software
- Testing carried out on the software
- Configuration and cyber Security management
- Software Maintenance and resolution of software issues: how to apply a corrective and preventive actions process?
- Course evaluation, synthesis and conclusions
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|About the trainer|
Sara Jafari, PhD