Biological Safety Evaluation Training - ISO 10993 Series

Course code BS1

Introductory Biological safety evaluation course ISO 10993 series (half a day)

Qserve Consultancy in conjunction with Qserve America has developed a course for medical device industry professionals who covers all aspects of the biological safety evaluation of medical devices or components thereof. Qserve offers this course in English and/or in Dutch, at Qserve offices, external locations and on-site at your own organization in both the EU and America.

The interaction between a so called biomaterial and its surrounding cells, tissues and tissue fluids is a dynamic system: living cells, tissues and tissue fluids can influence the biomaterial characteristics and the biomaterial can in turn influence the behaviour and viability of cells, and the tissue structure and tissue fluid composition. This interactive system becomes even more complex when we are dealing with a biodegradable material or when a material creates a cellular response that is intended, which in another situation would be regarded as “not acceptable”.

A material is biologically safe when it performs satisfactory in the application under consideration. In other words: a material is biologically safe when its biological safety risks are acceptable when weighed against its performance and application benefits. When the EU medical device regulations (MDD) or, the FDA’s regulations regarding biological safety, require that a medical device shall be biologically safe this means, in practice, that we have to perform a biological safety “risk assessment” on the device to estimate if the biological safety risks are acceptable or not. In addition, it requires that we adopt control measures to limit the (residual) biological safety risks to an acceptable level. This exercise is not only limited to the design process but extends to the routine purchasing and production processes. As such, biological safety evaluation is part of the overall risk management process according to ISO 14971.

Course Description:

This half-day course is designed to provide participants with a basic understanding of the role of biological safety evaluation in the design process and the production process. The course will follow the Risk Management process approach. It will provide help in identifying the potential causes of failure originating from product and material characteristics, production process aspects and use aspects, which might influence the level of biological safety risk. The course will present an overview of related biological safety hazards and give insights into overall biological safety risk estimation. The implementation of various biological safety control measures is considered. The link between biological safety evaluation, risk management and the Quality Management System will be a guiding line throughout the course.

Practical examples will be used to illustrate the above.

Course Objectives:

• To provide participants with a broad understanding of the role of biological safety evaluation in the design and production process in the medical device Industry
• To (re)acquaint participants with the latest EU and FDA requirements regarding biological safety evaluation
• To provide participants with a comprehensive overview of ISO 10993 series of standards
• To give participants the practical tools for implementing ISO 10993 requirements
• Recognition of the linkage between ISO 10993, ISO 14971 and the Quality Management System

Who should attend:

There are no pre-requisites for this course. This course is aimed at:

• Design Team Members
• R&D Managers
• QA/RA Managers
• Product and Production Managers
• Internal Auditors

Course Materials:

Participants will receive a comprehensive course manual with reference materials, and upon successful completion of the course a "certificate of attendance".

For more information, please complete the info request form in the "Contact Us" section, quoting the course code.