8:00 a.m. – 8:30 a.m.

Continental Breakfast

8:30 a.m. – 8:45 a.m.

Welcome and Introduction by Chairperson

8:45 a.m. – 9:30 a.m.

U.S. Medical Device Reporting – Part 1: U.S. FDA Perspective

If you’ve noticed a disproportionate number of warning letters for Part 803 – Medical Device Reporting, you’re not alone. The bulk of your Medical Device Reports (MDRs) citations are likely due to inadequate procedures — they account for nearly 90% of all MDR citations.

Get a clear explanation of the MDR requirements, common problems and reportable complaints. Reduce warning letters when you identify:

• How to evaluate complaints for reportability
• The criteria for reporting
• The investigation requirements
• The timeline for reporting
• How to keep solid records (the MDR event file)
• How to report using FDA’s eSubmitter

9:30 a.m. – 10:15 a.m.

EU Manufacturers Incident Reports – Part 2: EU Perspective

Don’t let yourself get tripped up by EU-MDR’s and IVDR’s new Manufacturer’s Incident Report (MIR). True: the new, more-elaborate form is complicated and requires a great deal of information — everything from an historical analysis of similar incidents to classification using the International Medical Device Regulators Forum (IMDRF) coding system.But when you know how to implement a solid system to identify and report serious incidents using MIR, you’ll avoid letters requesting resubmissions, which would otherwise cost you time and money.

Save time and money by avoiding resubmission requests. Attend to find out all about the new EU-MIR:

• How to determine a serious incident, including subsequent classification to determine reportability
• The information required for a successful submission
• How best to complete the MIR
• How to submit the MIR the right way

10:15 a.m. – 10:30 a.m.

Refreshment Break

10:30 a.m. – 12:00 p.m.

Mock Trial: The Product Liability Lawsuit

What you don’t know could bankrupt you: medical device manufacturers don’t always understand the implications of a product liability lawsuit. This mock trial will hit home the points you absolutely must understand to protect your business, all while providing some enjoyable entertainment.

The premise: During an in-patient medical procedure, a patient suffered harm. The patient is suing the hospital where the procedure took place, the doctor who performed the procedure and the manufacturer that made the device. The patient hires an attorney who then hires an expert witness to review the manufacturer’s documentation.

The discovery phase can require the manufacturer to produce thousands of pages of historical documents extending over years. A set of scripted vignettes is told from the expert witness point of view as she receives, reviews and comments on the manufacturer’s documentation. A “stage manager” will explain each vignette.

You — the audience members — are the jury. Each jury member gets a simple jury form with some choices. At the end of the trial, you’ll fill out the form and submit it to a member of the FDAnews team in return for admittance to lunch. During lunch, the FDAnews staff will compile the results and announce the verdict.

Come away not only energized, but with a deep understanding of business best practices to prevent debilitating lawsuits:

• Issues to consider in product development, manufacture and quality
• Product liability concerns — they can present themselves years after shipment
• Issues surrounding record retention and how to counteract them

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 1:45 p.m.

Correction & Removals, Medical Device Recalls and Closure – Part 1: U.S. FDA Perspective

Do you understand the U.S. process for correction and removals, device recall and closure? With a great deal of incorrect folklore being shared, it pays for manufacturers to be in the know when it comes to the multiple interlocking processes and multiple players involved.

Go through the U.S. process from beginning to end. You’ll be able to identify, navigate and use to your advantage the exceptions, the required records and the various reporting methods and their issues. This will help you ensure any corrections, removals, recalls or closures have the minimum impact on your business:

• How to get a handle on the various steps and participants
• Once and for all: the manufacturer does not determine the recall class or the depth of the recall
• What to include in a recall plan, should FDA require one
• Periodic reporting — what’s required by FDA?

1:45 p.m. – 2:30 p.m.

EU-MDR/IVDR Field Safety Corrective Actions – Part 2: EU Perspective

If you’re not completely clear on new EU-MDR/IVDR Field Safety Corrective Actions (FSCAs), you could be putting your business at risk. For instance, did you know the EU system has no recall classes? But the latest EU regulations do have requirements for a vigilance system that includes situations where a marketed device needs an update or some similar action. Fail to file your FSCA, Field Safety Notice (FSN) or other reports with the Competent Authorities (CA) — or file improperly — and you’ll incur unwanted costs.

Attend this presentation to go through the EU process from start to finish, ensuring your business complies:

• The various steps involved, from filing an FSCA, writing a Field Safety Notice (FSN) that tells the user or patient how to handle the situation, submitting the FSCA and FSN to the Competent Authorities (CA), analyzing the reason for the FSCA, implementing corrective action and filing additional reports with the CA
• Exactly who the relevant participants are so you know whom to contact when for maximum efficiency

2:30 p.m. – 2:45 p.m.

Refreshment Break

2:45 p.m. – 4:00 p.m.

ISO 14971:2019 – Risk Management Systems

Are you ready to implement ISO 14971:2019? What about EN ISO 14971:2019? With FDA recognizing ISO 14971:2019 as a consensus standard, you must prepare to implement it within your risk management systems to ensure compliance.

Receive an overview of the new international standard and hear about the changes from the previous version. After attending, you’ll be able to strengthen your processes to avoid noncompliance with:

• Practical ways to implement the new international standard and the EU variant in one unified quality management system and risk management system
• Understanding the issues involved and how to overcome them
• How to prepare implementation plans to remain compliant

4:00 p.m. – 4:45 p.m.

EU-MDR/IVDR Postmarket Surveillance

EU-MDR/IVDR’s new regulations require a detailed system for postmarket surveillance (PMS). Fail to create a detailed plan and various reports and you could risk fines, seizure of products, imposition of special compliance contracts and worse. When you take a more proactive approach to PMS, your company develops a reputation for producing ever-more-reliable and safer devices, not to mention that it reduces complaint-handling costs thanks to fewer incidents and greater customer loyalty.

Session attendees will gain insight into implementing an effective PMS system:

• Detailed information on PMS
• The associated reports (which change by device class)
• Other processes associated with the PMS system, including risk management

4:45 p.m.

Closing Comments by Chairperson, Steven Niedelman