Generating Risk-Based Design Input Early in the Design Process

is being presented by Bernard Bosley, Risk Management Consultant, of Koumu Engineering, Inc. and airs on Thursday, February 10th, 2011. For more details or to register please visit our site at www.fxconferences.com

Effective risk management requires analysis before the device is designed. This is essential for risk-based design input, and if it is not done early, then the risk information has little impact on the design. However, although it is required, the international standard for risk management (ISO 14971) gives very little guidance in this area.

This audio conference presentation shows how to accomplish risk-based design input early in the design process. It is intended for people who already have a basic understanding of risk management but are interested in ways to improve effectiveness in some of the more difficult and challenging areas of risk analysis.

Statistical Concepts of Medical Device Process Validation

is being presented by Dan O'Leary, President, of Ombu Enterprises and airs on Tuesday, October 5th, 2010. For more details or to register, please visit our site at www.fxconferences.com

Process validation is an important element in medical device manufacturing, and this audio conference looks at the underlying statistical concepts to perform an effective process validation, examining elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485.

When you cannot (or do not) fully verify process results by subsequent inspection and test this leads to sampling plans, and in this presentation our speaker discusses the use of attribute sampling plans in this context. When you validate the process with a high degree of assurance, this means your process achieves a certain process capability. The presentation looks at the concepts of process capability, especially the use of common processes capability indices, Cp and Cpk.

Process validation often employs three phases, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). One role of OQ explores the parameter space that defines the process and selects challenge points as part of the qualification protocol. This naturally leads to Designed Experiments as the exploratory tool. Designed experiments determine the limits of the parameter space for the process. The same techniques, especially full and fractional factorial experiments, can establish “worst case” conditions that become challenge points for the OQ phase of process validation.

Lastly, Risk Management (ISO 14971) includes production information. This leads directly to validated processes since these are often the production processes that carry the greatest risk.

A Practical Approach to Medical Device Risk Management

is being presented by Harvey Rudolph, Ph.D., HRRM, LLC, Risk Management Consultant and airs on Tuesday, August 3rd, 2010. For more details or to register please visit our site at www.fxconferences.com

Risk management is required by almost all regulatory bodies and is necessary for implementing many standards that medical device manufacturers use in designing and developing their products. Over the past ten years, most manufacturers have tried to model their risk management system on the one described in ISO 14971, because that is the one accepted by most regulatory bodies and referenced in most standards. However, myriad problems have been encountered in trying to implement risk management within existing quality management systems. Why is this? If ISO 14971 is so great, why isn’t it easier to do? What are the factors inhibiting success in making risk management work? In this audio conference, leading risk management expert Dr. Harvey Rudolph discusses some of the major issues facing medical device companies, and practical solutions.

Best Practices for Implementing ISO14971:2007

Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971

In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Manufacturers, however, still struggle to comply with ISO14971 and find a meaningful way to introduce risk management to the overall operating framework.

In this audio conference, Mr. Weber discusses the elements of risk management, the current interpretations of regulatory requirements, as well as advice on implementation of a compliant risk management process. ISO 14971:2007 helps companies input risk management strategies, it can help many types of businesses from software-based to broadband provision-related enterprises working with devices. Additionally, the presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.

Best Practices for Implementing ISO14971:2007 was presented by Markus Weber, Principal Consultant, with System Safety Inc. and aired on 2008-02-21. For more details or to download this event, please visit our site at www.fxconferences.com

Friday special - save 75% on "Hazard Analysis for Medical Devices Under IEC60601 and ISO14971"

If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.

This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It discusses documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.

But hurry! If you purchase Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 by November 5, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

IEC 60601-1 3rd Edition: Setting the Standard for Electromedical Devices

The third edition of IEC 60601-1 is now a year old; however, this standard is so different from the second edition that manufacturers and certifiers alike have yet to get their act together. One of the major reasons for this is the explicit introduction of risk management as a part of IEC 60601-1.

Risk management is inextricably woven into the fabric of this standard. Not only is there a general requirement for manufacturers to establish a risk management process that conforms to ISO 14971 (clause 4.2), but there are also more than one hundred times where the standard directs manufacturers to determine risk acceptability in applying a particular clause.

This audio conference examines how risk management is used in the third edition, as well as the implication both for manufacturers and for third party certifiers.

IEC 60601-1 3rd Edition: Setting the Standard for Electromedical Devices was presented on 2007-02-15 and is available for download at www.fxconferences.com

Hazard Analysis for Medical Devices Under IEC60601 and ISO14971

If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.

This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It will discuss documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.

Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 is being presented by Markus Weber, Principal Consultant, with System Safety Inc. and airs on Thursday, March 19th, 2009. For more details or to register please visit our site www.fxconferences.com

This audio conference has been pre-approved by RAPS as eligible for one (1)credit toward a participant's RAC recertification upon completion.

Best Practices for Implementing ISO14971:2007

Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971.

In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Manufacturers, however, still struggle to comply with ISO14971 and find a meaningful way to introduce risk management to the overall operating framework.

In this audio conference, Mr. Weber discusses the elements of risk management, the current interpretations of regulatory requirements, as well as advice on implementation of a compliant risk management process. Additionally, the presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.

Best Practices for Implementing ISO14971:2007 aired on 2008-02-21 and is available for download at www.fxconferences.com

Risk Management Best Practices for Medical Devices

Managing risk has always been an integral part of medical device development, but is now becoming more integrated with quality management systems. Previous experience with “risk assessment” had been the application of risk analysis to determine specific risks associated with a device. This is no longer the case with a quality management system such as ISO 13485 and the recently updated ISO 14971 standard defining and clarifying the risk management process.

This presentation helps organizations to better understand how risk management can reach its full potential as a management tool. When there are complaints or adverse events for a product family, have these been addressed in the risk analysis? When does the risk management file get updated or reviewed? How does an organization go about creating a system to assure that risk management fulfills that role within the product life cycle? These questions will be answered as the speaker walks attendees through the process of implementing a risk management system within a medical device company.

Risk Management Best Practices for Medical Devices is being presented by Richard Vincins, Senior Consultant, with Emergo Group and airs on Thursday, January 22, 2009. For more details, or to register for this audio conference, please visit our site www.fxconferences.com

IEC 60601-1 3rd Edition: Setting the Standard for Electromedical Devices

The third edition of IEC 60601-1 is now a year old; however, this standard is so different from the second edition that manufacturers and certifiers alike have yet to get their act together. One of the major reasons for this is the explicit introduction of risk management as a part of IEC 60601-1.

Risk management is inextricably woven into the fabric of this standard. Not only is there a general requirement for manufacturers to establish a risk management process that conforms to ISO 14971 (clause 4.2), but there are also more than one hundred times where the standard directs manufacturers to determine risk acceptability in applying a particular clause.

This audio conference will examine how risk management is used in the third edition, as well as the implication both for manufacturers and for third party certifiers.

This event is presented by Harvey Rudolph of Underwriters Laboratories. To learn more, please visit www.fxconferences.com.

Best Practices for Implementing ISO14971:2007

Implementing risk management into the medical device development process has become a regulatory necessity. However manufacturers still struggle to not only fulfill the requirements of ISO 14971, but also to find ways to implement risk management into the overall operating framework in a meaningful way.

This audio conference discusses the elements of risk management, the regulatory requirements and current interpretations, as well as implementation of a compliant risk management process. Additionally, the presentation will provide practical tips to optimize the benefits of implementing risk management into the development process while at the same time minimizing the administrative burden imposed by the additional process.

This audio conference is presented by Markus Weber of System Safety Inc. To learn more, visit www.fxconferences.com.