Design Control of Investigational Devices
- Complaints to be Monitorable under ISO 14155 (2010)
The new ISO 14155 "Clinical investigation of medical devices in human subjects - good clinical practices" will be published in 2010. It is likely to be recognized by FDA, which will give it tremendous standing within the US, as well as EU and Japan. The standard will alter the foundation of every clinical trial conducted. It makes the need for investigational device design control paramount and its deficiency monitorable and reportable within the adverse event reporting system.
Complaints Result from Poor Design Control
For the first time, the medical device good clinical practices will contain a definition for complaints. A complaint being a written, electronic, or oral communication that alleges deficiencies related to the identify, quality, durability, reliability, safety, or performance of an investigational device. A complaint can come from anyone; need only be alleged, not proven; do not require or even involve medical harm, and may result from problems with the product or problems with its use.
Monitoring for Complaints
Next the standard tells us to document and report all complaints such as malfunctions, misuses, and use errors as part of routine study documentation. The complaint may come from any source: subject, caregiver, family member, or janitor. Even oral complaints must be documented in writing by the study staff, and captured on case report forms. The burden for complaint-source verification and managing the paperwork will fall naturally to the monitor.
Finally, the standard comes full circle and instructs sponsors to report complaints to regulatory authorities, data safety monitoring boards, and other investigative sites; and to include a summary table in the final report.
Embarrassing to Monitors
Complaints will be embarrassing to monitors because you serve as the primary liaison between study staff and sponsors. Complaints result from poor designs, poorly tested, and barely validated--in other words, from poorly implemented design controls.
In this e-conference we will discuss what questions you should ask your R&D department and what documentation you should get from them before you initiate a study. You'll learn how to monitor for design elements. And you'll learn about real-life situations in which studies didn't provide the data required by FDA.
What are Design Controls
Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process, i.e., a system of checks and balances. Design controls make systematic assessment of the design an integral part of development. As a result, deficiencies in design input requirements, and discrepancies between the proposed designs and requirements, are made evident and corrected early in the development process and to avoid complaints during the clinical trial. Design controls increase the likelihood that the design transferred to production will translate into a device that is appropriate for its intended use.
Our objective: to learn the questions how to grill R&D so your study has a chance of success.
You will receive
[x] PowerPoint slides.
[x] A questionnaire/checklist to use as a guide.
[x] Expert and experienced speaker.
[x] Chance for Q&A.
[x] CEUs and certificate of attendance.
Who should attend
[x] Clinical research professionals who design and implement clinical trials.
[x] IRBs fearful of approving non-existent devices.
[x] CROs working with start-ups who don't know the regulations.
[x] Regulatory professionals who report clinical data.
[x] Investigator-sponsors who want to assure their investigational assembly-of-parts is legit.
[x] Company managers and decision-makers.
F. David Rothkopf, MSME, MBA, has more than 20 years of professional strategic experience in the development, quality and regulatory control of medical devices. He is currently the President and Founding Principal at MEDIcept, which was established in 1997 to offer engineering, quality, and regulatory consulting assistance to the medical device and blood plasma industry.
Previous to MEDIcept, Mr. Rothkopf was instrumental in starting three medical device companies. Two companies, mRad and Zmed, were subsequently sold to large international corporations. Mr. Rothkopf also founded SON Medical, a software regulatory consulting firm, and was a Senior Quality Consultant at MDCI. Prior to Mr. Rothkopf’s entrepreneurial pursuits, he was the Vice President of Quality and Regulatory Affairs at Urovations, the Director of Quality at Uromed and a Project Leader at Johnson and Johnson Professional.
Over his career, Mr. Rothkopf has assisted over 100 companies with the aid they require to navigate the national and international regulatory paths. He has performed well over 150 ISO 9000, ISO 13485 and FDA-style audits over the last 10 years. Mr. Rothkopf has submitted over fifty-five 510ks and PMAs and with other MEDIcept personnel has developed over 100 submissions. He has leveraged his extensive QA, regulatory, and clinical knowledge and his personal relationships with regulated bodies for the advantage of his clients by finding the most cost effective and efficient method to federal compliance.
Mr. Rothkopf holds Bachelor’s and Master’s degrees in Mechanical Engineering from Worcester Polytechnic Institute and an MBA from Boston University. He can be reached at email@example.com.
System requirements, date, time, registration
The purchase is $423 for OnDemand access and $473 for the CD. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.