Day 2 – Friday, Oct. 9, 2020
Welcome and Introduction by Chairperson
King & Spalding LLP
former FDA Deputy Associate Commissioner for Regulatory Operations
ISO 14971:2019 – Risk Management Systems
FDA and Life Sciences
King & Spalding
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:
- Understanding how the updates in ISO 14971:2019 impact your current risk management process
- Harmonizing risk management across all risk-based elements of the QMS using ISO 14971:2019 as a guide
- How to prepare implementation plans to remain compliant
EU-MDR and IVDR Post-Market Surveillance
Regulatory & Quality Solutions (R&Q)
EU-MDR’s and IVDR’s new regulations require a detailed system for post-market 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.
Learn how to implement an effective PMS system:
- Detailed information on PMS
- Know the associated reports (which change by device class)
- Other processes associated with the PMS system, including risk management
Break
Medical Device Data Analysis Methods: An In-depth Virtual Workshop
Ombu Enterprises LLC
As a device manufacturer, you must analyze for product improvement and to satisfy regulatory requirements in Quality System Requirements (QSR) and ISO 13485:2016. But are you completely clear on what the requirements are and, more importantly, what techniques to use? If not, you risk noncompliance.
This workshop identifies methods based on ISO/TR 10017:2003, which describes statistical techniques for a quality management system (QMS). While the standard describes methods, it provides no implementation details. This coupled with the fact that there are other methods available mean you need guidance on how to make your QMS work to your best advantage.
Get the exact guidance you need to ensure your products remain viable. Statistical techniques covered include:
- Descriptive statistics
- Hypothesis testing
- Process capability analysis
- Sampling
You’ll receive data sets and descriptions during the session, so you can work on the examples. This workshop does not use Minitab, because many small companies do not have it.