The amendment 2007/47/EC to the Medical Devices Directive concerning software and the FDA’s Quality System Regulation requirements for software as expressed in 21 CFR 820.30(g), 70(i), 75 all requires the manufacturer to incorporate 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 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.
This course is designed to give delegates an understanding of the EN 62304 standard as a tool to fulfill the regulatory requirements defined in the FDA’s GMP/Quality System Regulation 21 CFR Part 820 for software and the Essential Requirements of the Medical devices Directive (93/42/EEC).
The 2-day 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 management to medical devices and AAMI /TIR 32 Medical device software risk management into the software life-cycle processes will be shown
All current documentation of the FDA and EU software regulatory requirements will be included in the course binder.
The format will include lectures, discussions groups and case studies.
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.
Poul Schmidt-Andersen of Copenhagen Medical Devices Consulting Aps, holds a B.Sc. E.E. and a B. Comm. in business / administration. He has been CEO of the Danish National Notified Body and is a Lead Auditor for EN ISO 9001 / EN 46001 / EN ISO 13485 quality systems and for the Medical Devices Directive (MDD). He is a recognized FDA inspector with respect to the US requirements of the Code of Federal Regulation 21 Part 820 and has been trained by the FDA as a Pre-market Notification 510(k) reviewer under the Mutual Recognition Agreement (Medical Devices Annex) between the European Commission and the US.
English course material and presentations in English/Danish depending of preference by the delegates