Validation of Medical Device Software
Course Category: Medical Devices
Course Title: Validation of Medical Device Software
An intensive 1.5 day course on requirements for validation of medical device software as contained in EN (IEC) 62034. The recent amendments to the EU Directives: Medical Devices (93/42/EEC), Active Implantable Medical Devices (90/385/EEC) and Biocidal products (98/8/EC) as expressed in the Directive 2007/47/EC concerning software and the FDA's Quality System Regulation requirements for software as expressed in 21 CFR 820.30(g), 70(i), 75, all require the manufacturer to incorpo¬rate software life-cycle processes into his quality system. The new standard EN (IEC) 62304 Medical device software – software life-cycle processes is a tool to fulfil these requirements. The IEC 62304 was harmonized in the European Union on 28th November 2008. Compliance with EN/IEC 62304 now provides a presumption of conformity with the above men¬tioned Directives in relation to software. Furthermore, IEC 62304 is recognised by FDA as a consensus standard. The standard provides a framework of life-cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software. This standard provides requirements for each life-cycle process.
Course Presenter
This course is presented with our training partner, Tom Donnelly of Medicom Consulting.
Who should attend?
- The course is particularly suitable for those in the Healthcare Products industry who are actively engaged in developing or supporting regulatory compliance of medical device programmable systems.
- Some knowledge of medical device regulatory management systems is assumed. However, there will be a brief introduction to ensure that everyone is "up to speed". It is recommended that those attending the course either:
- are or will be involved at some level in the implementation of compliance to FDA/EU Regulations and / or
- have some experience of Programmable Systems, software development and conformity assessment to FDA, Medical Device Directive (93/42/EEC) or other requirements
Learning Objectives
- This course is designed to give delegates an understanding of the EN 62304 standard as a tool to fulfil the regulatory requirements defined in the FDA's Quality System Regulation 21 CFR Part 820 for software and the Essential Requirements of the amended Medical Devices Directive (93/42/EEC). Furthermore, the delegates will receive an overview of the extent of documentation required to obtain an EU/US clearance for a medical device containing software.
Course Structure
This course is a 16 hour/2 day course.
Course Start: 09:00a.m & Course Finish: 17:00p.m
A detailed course breakdown is as follows:
- The course details the software validation requirements that need to be addressed during design control [21CFR Part 820.30(g) and §7.3 of the EN ISO 13485] for software developments.
- There will be sessions on software risk management, development life-cycle, architecture, design, software verification and validation.
- Software validation of proprietary medical device products, subcontracted and off-the-shelf software will also be covered.
- Incorporation of EN ISO 14971, Medical devices – Risk management – Application of risk manage¬ment to medical devices and AAMI /TIR 32 Medical device software risk management into the software life-cycle processes will be shown. Also references to the coming guideline IEC/TR 80002-1 "Medical device software – Guideline on the application of ISO 14971 to medi¬cal device software" will be given.
- Current documentation of the FDA and EU relating to software regulatory requirements will be included in the course binder.
Training Methodology
The course presents the Validation of Medical Device Software comprehensively, it uses case studies, interactive sessions as well as formal presentations. Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course. This course can also be tailored to meet your specific requirements.
What's Included on the course
- Comprehensive Course Manual
- Delivery by Expert (s) with real life experience
- Additional Handouts
- Training Certificate of Attendance
Further Information
Kelmac Group offer all of our Training Solutions on an In Company/In House basis. These solutions can be tailored to meet the specific needs and requirements of the client.
Our fees are very competitive and if you would like further information, please contact our office directly on +353 (61) 4491224 or email info@kelmacgroup.com
€1,095*/Person-
21 May 2012
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11 June 2012
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13 June 2012
