February 19-20, 2019

Medical Device Risk Management
Atlanta, GA

The gale force flags are flying!

Risk management is just plain hard — complicated, conflicted, confusing. And it’s getting even harder.

The international standard is under revision. While the changes in the process are not intended as “major”, the new standard adds new definitions… changes the clause numbering… introduces new requirements… changes many of the annexes, and moves them to a new document.

In a sister storm, the EU is in transition to new regulations. There are new concepts… new risk reduction requirements… and new applications. Two areas of impact are side-effects (residual risk) and benefit-risk analysis as a life-cycle requirement.

The storm surge affects the many standards that require ISO 14971:2007. Some of them are already in various stages of transition, but all will need an update. Your procedures in these areas require a major refit.

  • ISO 10993-1:2018 on biocompatibility is the new version — it currently requires ISO 14971:2007 but will need an adjustment.
  • IEC 62366-1:2015 on usability has an amendment underway that may include some issues related to the new risk management standard.
  • Other areas that will require adjustment — at the SOP level initially — include software, electrical medical devices, and animal tissues.
  • Your risk management procedures will require a major overhaul.

This workshop — led by industry expert Dan O’Leary — provides the information you need to batten down the hatches and survive the storms. Dan will explain the new version of 14971 and its implementation. He’ll cover the new EU regulation’s risk management requirements through the product life cycle (initial CE Mark and post-market issues). And provide current information on the standards that require risk management and their implementation. During the workshop you’ll:

  • Learn the fundamental concepts of risk management
  • Understand the regulatory structure including the US, Canada, the EU current state, and the EU future state
  • Review recent FDA Warning Letters and understand how to avoid their problems
  • Learn the process flow in the new standard, ISO 14971:xxxx
  • Understand the details of the EU variant, EN ISO 14971:xxxx including the five Z annexes
  • Understand the risk management changes arising from the EU-MDR and EU-IVDR
  • Review the potential relationship between the ISO 14971:xxxx Risk Management System (RMS) and an ISO 13485:2016 Quality Management System (QMS)
  • Review the risk management audit tasks from the MDSAP Audit Model
  • Understand the role of risk management in post-market surveillance
  • Review the entire Workshop agenda.

Your risk management guide is Dan O’Leary, a favorite presenter at dozens of FDAnews-sponsored workshops. Dan provides the understanding and practical tools to join the disparate pieces into a coherent whole and create a solid foundation for the coming changes. Dan boasts more than 30 years’ experience in quality, operations and program management in regulated industries including aviation, defense, medical devices and clinical labs.

Risk management affects nearly every aspect of medical device manufacture. Yet many devicemakers lag behind the curve, courting warning letters or worse. Get your operation up to speed quickly and easily.

For details and registration, Click Here

April 15-18, 2019

18th Annual Design of Medical Devices Conference
Graduate Minneapolis & McNamara Alumni Center
Minneapolis, MN

The University of Minnesota’s Medical Devices Center (part of the Institute for Engineering in Medicine), the College of Science and Engineering, and the Department of Mechanical Engineering presents the 18th Annual Design of Medical Devices Conference, April 15-18, 2019. The world's largest medical device conference will be held at Graduate Minneapolis & McNamara Alumni Center, located on the University of Minnesota Twin Cities Campus. The DMD Conference brings together medical device designers, manufacturers, researchers and representatives from academia and the public sector.

Conference Goals

  • Provide a national forum to bring together world-class medical device designers, researchers, manufacturers, and the public sector to share perspectives and innovations in medical device design,
  • Showcase the University of Minnesota as a leader in the medical device community, and
  • Raise funds from corporate sponsorship to support medical device education at the University of Minnesota
Call for Papers

The DMD 2019 Conference seeks original papers that demonstrate new technologies and applications in the field of medical device design. Submissions from academic and industry researchers, clinicians and practitioners are encouraged. Papers should present an unbiased description of an experiment, product or business method related to medical devices. Repeated references to branded products or trade names, or excessive use of corporate logos or trademarks in illustrations is discouraged. Authors of contributed papers are likely to be asked to serve as reviewers.

A number of papers will be selected to be presented in one of the Advances in Medical Devices sessions and ten papers, describing medical device designs with a potential for commercialization, will be invited for participation in the Three-in-Five Competition.

All accepted papers will be published in the 2019 Proceedings of the Design of Medical Devices Conference in the ASME Digital Collection. DMD Conference registration and presentation of the paper in the conference poster session is required for publication of the paper.

High-quality accepted papers will be flagged in the review process and those authors will be invited to submit a longer version of their work for publication in the ASME Journal of Medical Devices. These papers will undergo an expedited review process, handled by the JMED editors.

November 1, 2018 - Draft Papers Due


Registration opens January 1, 2019! Early Bird Deadline is March 10. Complete registration information can be found at

Sponsorship Opportunities Available

The mission of the Design of Medical Devices conference is to facilitate collaboration between academia and industry. Exhibit Space is limited. Deadline to sponsor is March 1, 2019. To learn more, contact Jenny Holden, Conference Administrator at

For more information, please visit or contact

April 23-25, 2019

Medical Device Quality Congress
Bethesda, MD

Testimonials From Past Attendees:

“I love coming away having learned something new that I didn’t realize I was missing.” – Nikki Willett, Chief Stagey Officer, ComplianceQuest

“I liked the breadth of information presented and the knowledge of the speaker. I also liked the informal atmosphere that allows for questions during the day and not just during specific.”

– Jennifer Bohan, Quality Manager, Polymer Science said of the Post-market Surveillance post-conference training

“Great information and excellent speakers.”

For details and registration, Click Here

Training Programs

Phlebotomy Training in 2 days!

Learn to draw blood quickly. The program consists of one day online training at your own pace and one day hands-on training in the classroom setting. We come to your location. Train now!


December 18, 2018

FDAnews/CenterWatch Webinar

Medical Device Voluntary Malfunction Disclosure Regulation
Are You Up to Date on the Latest Developments?

11:00 p.m. - 12:30 p.m. EDT

The Voluntary Malfunction Summary Reporting Program was finalized in August 2018 and lets manufacturers report certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis instead of the typical 30 days for each individual report.

Over the course of 90 fast-paced minutes, Stephanie Resnik and Christopher Hanson — associates at Covington & Burling LLP, Washington, DC — will discuss which products are covered, how the program will help increase efficiency and whether it makes sense to take part in the program. You’ll learn:

  • Background of the Voluntary Malfunction Summary Reporting Program including:
    • Origins of the program
    • FDA’s intentions in establishing the program
    • Types of manufacturers, devices, and events eligible to participate in the program
  • How the Voluntary Malfunction Summary Reporting Program differs from individual malfunction reporting
  • Benefits to device manufacturers including the efficiency advantages offered by the program
  • Conditions under which the program is not available to manufacturers
  • And much more…

Join us on December 18 and discover the advantages of participating in the Voluntary Malfunction Summary Reporting Program

Who Will Benefit
  • Quality Managers
  • Quality Engineers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners


December 18, 2018

FDAnews/CenterWatch Webinar

Medical Device Cybersecurity Risks & Best Practices
Navigating the Nuanced Cyber Regulatory Waters

1:30 p.m. - 3:00 p.m. EDT

Smart medical devices have underlying cybersecurity and privacy risks. They are also top targets from a host of global attackers from nation states to sophisticated criminal gangs. The health sector — including medical device manufacturers as well as pharmaceutical and biotech companies — faces uncharted regulatory and liability risks.

FDAnews has invited global cybersecurity expert Norma Krayem to walk you through the rapidly changing global regulatory landscape and show you new coping strategies.

Over the course of 90 fast-paced minutes, Ms. Krayem will move from the Cybersecurity Executive Order 13800 to HIPAA, Homeland Security and more:

  • Cybersecurity-triggered changes in the interpretation of HIPAA, and enforcement by the HHS Office of Civil Rights, as they affect quality and regulatory matters
  • Cybersecurity as an enterprise risk management issue affecting security, risk and privacy functions in device firms
  • Homeland security: How DHS cybersecurity initiatives, including the Automated Information Sharing (AIS) program, can help you understand the threat from nation-states, non-state actors and other potential attackers
  • FDA’s evolving focus on cybersecurity and how it impacts the risk, responsibilities, and regulation of companies
  • The Cybersecurity Information Sharing Act (CISA) and the Protected Critical Infrastructure Information (PCII) as potential “safe harbors”
  • New international privacy and cybersecurity laws impacting the health sector
  • And much more

With U.S. agencies — FDA, HHS, DHS — all at work on new sector risk bulletins and re-evaluation of current rules such as HIPAA, and global regulators equally involved, this is a pressing matter. Address it now, by committing an hour and a half of your time to this timely learning session

Who Will Benefit

Cybersecurity is a multi-discipline activity, so team participation in the presentation is important. Team members include:

  • Design Engineers
  • Software Engineers
  • Software Validation Specialists
  • Risk Managers
  • Complaint Managers
  • Complaint Analysts
  • Regulatory Affairs Managers
  • Submission Specialists


January 10, 2019

FDAnews/CenterWatch Webinar

Sampling Plans for Quality Audits

1:30 p.m. - 3:00 p.m. EDT

Sampling raises questions for the auditor, such as the number of records to sample, counting nonconforming records and limits on acceptance. If a record has three errors does the auditor count it three times — one time for each error — or one time as a nonconforming record?

Some auditors determine the sample size without using statistical techniques. Sampling the records in an audit is not the same as sampling at incoming inspection — the purpose is different, so the method changes. An audit may need to determine the error rate in a process, or least show that it is not too great. Dan O’Leary, one of FDAnews’s most popular presenters, will examine the issues in audit sampling and provide the answers you need for planning. Over the course of 90-minutes you’ll:

  • Learn the concepts of sampling applied to quality audits
  • Understand the difference between a nonconformance and nonconformities
  • Learn about the use of (non-statistical) convenience samples
  • Understand the use of standard sampling plans in an audit
  • Understand the role of the binomial distribution to understand audit sampling
  • Understand FDA’s QSIT sampling plans
  • Bonus Material: Participants receive an explanation of how to calculate exact binomial confidence intervals using an Excel worksheet.

Quality audits provide assurance to management that the quality system operates effectively. This presentation provides the information you need to use sampling for quality audits.

Who Will Benefit
  • Quality Managers
  • Audit Managers
  • Lead Quality Auditors
  • Quality Auditors
  • Regulatory Affairs Managers