Risk Management Throughout the Medical Device Product Lifecycle

is being presented by Bill White, Senior Consultant, with Quality System Strategies LLC and airs on Thursday, March 17th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Management of product risk is not addressed prominently either in the FDA’s Quality System Registration or in ISO 13485:2003. Nevertheless, in order to ensure the well being of customers and the company itself, each medical device company must incorporate product risk management concepts throughout its quality management system. The Global Harmonization Task Force issued a guidance document which provides an excellent starting point in identifying the processes that need to include risk management. However, going beyond the guidance document calls attention to both opportunities and pitfalls in product risk management.

This audio conference reviews senior management responsibilities and benefits related to product risk management. The speaker identifies the risk management principles to be incorporated throughout the quality management system, with particular emphasis on links between processes.

Risk Management for Medical Devices

is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Wednesday, January 26th, 2011. For more details or to register, please visit our site at www.fxconferences.com

Risk Management is vital in medical device design, manufacturing, and post-market surveillance. The FDA QSR requires risk analysis in the design phase, but realizes the need for life cycle management through the complaint system. The FDA recognizes ISO 14971:2007 as a consensus standard. In the European Union, EN ISO 14971:2007 is a harmonized standard and notified bodies will expect full compliance. ISO 13485:2003 also calls out the standard as preferred method.

This audio conference introduces the concepts of Risk Management in ISO 14971:2007. It explains the flow of information from the Risk Management Plan to the Risk Management Report. It covers the differences among Hazard, Harm, and Risk and explains how to evaluate each of them. The program describes development of a Risk Evaluation Matrix taking into account the probability of occurrence and the severity of the harm. The standard requires a list of known and foreseeable hazards as well as foreseeable sequences of events that could result in harm. The presentation describes the tools (FMEA, FTA, and HAACP) and their application.

Marketing Your Medical Device in Canada

Despite the downturn in the global economy, Canada remains an important and growing market for medical device manufacturers. However, differences between Health Canada and FDA regulations and device classifications have resulted in some confusion over the best approach to take when entering the Canadian marketplace.

This presentation covers the basic steps you will need to take to obtain the appropriate licences for your company and/or medical device (e.g. Medical Device Licence or Medical Device Establishment Licence). The presentation includes a discussion about the Canadian Medical Device Regulations, the role of ISO 13485:2003 CMDCAS, and issues related to language translation.

Marketing Your Medical Device in Canada was presented by Daryl Wisdahl, Director, with Wisdahl Consulting Group and aired on 2008-11-20. For more details, or to download this conference please visit our site at www.fxconferences.com

Implementing a Quality Management System: ISO 13485

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer and regulatory requirements. One of the main objectives of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. It includes many of the elements of ISO 9001 but excludes some aspects not appropriate as regulatory requirements. ISO 13485:2003 is applicable to all medical device manufacturers, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, or if “product realization” (Clause 7) is not applicable, these can be excluded from the quality management system. However, organizations claiming conformity with ISO 13485:2003 must reflect these exclusions. The processes required by ISO 13485:2003, which are applicable to the medical device(s) but are outsourced, must be accounted for in the organization's quality management system. ISO 13485:2003 is used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.

This conference looks at the requirements of ISO 13485:2003 and some practical aspects of setting up a quality system for medical device manufacturers.

Implementing a Quality Management System: ISO 13485 is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Thursday, October 15, 2009. For more details or to register, please visit our site at www.fxconferences.com

Marketing Your Medical Device in Canada

Despite the downturn in the global economy, Canada remains an important and growing market for medical device manufacturers. However, differences between Health Canada and FDA regulations and device classifications have resulted in some confusion over the best approach to take when entering the Canadian marketplace.

This presentation covers the basic steps you will need to take to obtain the appropriate licences for your company and/or medical device (e.g. Medical Device Licence or Medical Device Establishment Licence). The presentation will include a discussion about the Canadian Medical Device Regulations, the role of ISO 13485:2003 CMDCAS, and issues related to language translation.

Marketing Your Medical Device in Canada is presented by Daryl Wisdahl, Director, of Wisdahl Consulting Group and airs on Thursday, Nov. 20, 2008. For more details or to register for this conference, please visit our site www.fxconferences.com

Introduction to ISO 13485:2003 and ISO 14969

ISO 13485:2003 has hit the street several years ago. Understanding the impact that these standards have on devices and diagnostics will help you to develop a forward-looking ISO strategy.

Drawing on her work with industry-leading device and diagnostic companies on ISO standards, Sue Spencer discusses the technical and strategic challenges being faced by those charged with maintain ISO. This audio conference walks you through the maze of updates to ISO 13485:2003 and provides insight to supporting guidance document ISO 14969.

Introduction to ISO 13485:2003 and ISO 14969 was recorded on 2003-07-16 and is now available for download at www.fxconferences.com

CE Marking: 7 Steps to Getting Started in Europe

With a population approaching a half-billion people, the EU represents arguably the most lucrative market today. However, before any medical device company can sell in Europe, it must first obtain the CE Mark. The process of obtaining approval to affix the CE Mark to your product differs significantly from the US FDA system.

This presentation covers the basic steps companies need to follow in obtaining the CE Mark, including a discussion about ISO 13485:2003 and how it differs from FDA Good Manufacturing Practices (GMP), issues related to language translation and labeling, creation of a Technical File and how this differs from the FDA 510(k) application, dealing with Notified Bodies, selecting an Authorized Representative and an overview of the costs and timelines involved in achieving certification.

CE Marking: 7 Steps to Getting Started in Europe was recorded on 2007-04-03 and is now available for download at www.fxconferences.com