Diligent, complete and correct implementation of risk management of software used in medical devices that takes into consideration the gaps and corrects them from the start of product development is absolutely imperative. This is because of two critical reasons:
- Gaps, incorrect or incomplete implementation can retard or delay or make the certification/approval of medical products impossible;
- Since most activities are closely linked to the development lifecycle; almost none of it can be retrospectively performed. This renders all activities performed till the identification of gaps useless and redundant; making it necessary to start from the beginning, no matter at what stage an anomaly is discovered.
Embedding software risk management into the bigger scope of overall risk management is the way forward if these fiascos have to be avoided.
Learn the ways of doing it right from start till finish
The proper ways of how to take all the necessary steps for designing, implementing and testing critical medical device software in a regulatory compliant environment will be the learning a two-day, live seminar being organized by GlobalCompliancePanel, a very respected provider of professional trainings for the regulatory compliance areas.
Markus Weber, Principal Consultant with System Safety, Inc., who specializes in safety engineering and risk management for critical medical devices, will be the course Director. To participate in this very important seminar, please log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900681SEMINAR?risk-management-medical-devices-Boston-MA
In line with globally applicable standard requirements
International consensus, reflected in globally applicable standard requirements such as ISO14971 and IEC62304, has led to risk management being a mandatory component of almost any activity in the medical device industry. This course will explain these requirements.
Given that software risk management has to be embedded into the bigger scope of overall risk management; Markus will introduce all the steps necessary to design, implement and test critical medical device software in a regulatory compliant environment while adhering to the principles of risk management. In addition, he will also address the system level risk management and the resulting interfaces to software.
Understanding safety assurance cases
The ‘Safety Case’ or ‘Assurance Case’ document is a well-established method to collect all safety related information together in one place to comprehensively summarize all risk related activities and to demonstrate the safe properties of a device. Currently only required for FDA infusion pump submissions; this documentation will most likely become mandatory for all devices. This course will introduce the basic concepts and content of safety assurance cases and will illustrate their usefulness for internal and external review of safety related information.
This seminar will use real-life examples and proven tips and tricks to make the application of risk management a practical and beneficial undertaking. It will address the system level issues of risk management as well as the increasingly important software related issues of critical systems. The concept of an assurance case will be introduced to make the combined effort towards designing, implementing and verifying a safe device transparent. The outcome of this learning is that it will help to comply with regulatory requirements with minimized overhead and resource burden.