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.

Advanced Human Factors Engineering

is being presented by Maria Shepherd, Principal, with Data Decision Group and airs on Tuesday, January 25th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com

FDA's expectations are changing. Medical manufacturers are required by FDA and other global regulatory bodies to prove that human factors considerations have been met during product design and development. FDA takes these human factors requirements seriously, requiring that the manufacturer perform a systematic assessment of the intended user(s), how the device will be used, the environment in which it will be used, and existing use-related hazards.

This audio conference presentation reviews guidance documents issued by FDA regarding its human factors initiative. The speaker also presents several examples of a human factors engineering project, including templates that have been designed to assist in the process of usability testing in the medical industry.

Human Factors Design, Testing & Risk Analysis

is being presented by William R. Mandel, Directory of Technology, with Oasis Medical Solutions and airs on Wednesday, August 25th, 2010. For more details or to register, please visit our site at www.fxconferences.com

Human factors study has become a key element for FDA scrutiny. It is also a challenging field because subjective perspectives are evaluated and used to create a quantitative analysis, which must be concrete and testable. Careful consideration and execution must be utilized in navigating this less-than-comfortable process.

This presentation explores the multidimensional aspects of human factors design and testing from initial conception to manufacturing, and how to compile the essential core human factors elements to add to the design history file. Understanding terminology is a key aspect of this process. The speaker also discusses the importance of risk analysis and its process in relation to human factors testing. Finally, we explore the fundamentals of performing human factors testing in a real-world scenario and examine the methods of turning data into concrete, acceptable, easy-to-understand documentation.

Quality Testing for Complex Medical Devices

is being presented by Lura Wolfe, Technical Quality Engineer & Consultant and airs on Wednesday, March 3, 2010. For more details or to register, please visit our site at www.fxconferences.com

Testing in complex software and hardware environments presents unique challenges in product development, and it is vital that your QA team be being able to meet these challenges and ensure quality. Agile development methodologies were implemented for quick creation and delivery of software, but they introduce new challenges when deliverables keep changing, timetables are shortened, and development complexity rapidly increases.

This audio conference presentation examines the testing methods typically used with complex medical devices. The speaker draws on first-hand experience and provides examples of test plans, test cases, and test lists, and discusses how to use documentation to create, track, and report testing results.

Effective Strategies for Successful Medical Device-CRO Partnerships in Post-Approval Studies

Outsourcing in the life sciences industry is an established business practice that saves time and money. Medical device post-approval studies differ in both subtle and considerable ways from that of drugs or biologics, including how to approach and conduct mandated post-marketing studies. Successful partners in this realm require a firm understanding not only of the regulations, but also how to nurture seamless, high-functioning project teams.

This conference provides insights into building successful CRO partnerships that focus on medical device manufacturer needs, including risk analyses, communication plans, safety considerations (adjudications and DSMBs), effective team building and setting milestones and metrics to track success.

Effective Strategies for Successful Medical Device-CRO Partnerships in Post-Approval Studies is being presented by Yvonne Albright and Barbara Vargas, Project Managers, with Covance Periapproval Services and airs on Thursday, April 16, 2009. For more details or to register, please visit our site at www.fxconferences.com

Effective Strategies for Successful Medical Device-CRO Partnerships in Post-Approval Studies

Outsourcing in the life sciences industry is an established business practice that saves time and money. Medical device post-approval studies differ in both subtle and considerable ways from that of drugs or biologics, including how to approach and conduct mandated post-marketing studies. Successful partners in this realm require a firm understanding not only of the regulations, but also how to nurture seamless, high-functioning project teams.

This conference will provide insights into building successful CRO partnerships that focus on medical device manufacturer needs, including risk analyses, communication plans, safety considerations (adjudications and DSMBs), effective team building and setting milestones and metrics to track success.

Effective Strategies for Successful Medical Device-CRO Partnerships in Post-Approval Studies is being presented by Yvonne Albright and Barbara Vargas, Project Managers, with Covance Periapproval Services and airs on Wednesday, March 11th, 2009. For more details or to register for this conference, please visit our site 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