There is no one-size-fits-all solution for addressing customer service and compliance issues caused by postmarket device problems.
Regulatory requirements are confusing and inconsistent, with each region following a different set of rules. The path to resolution can cross corrective action, adverse event reporting, design changes, regulatory submissions and field actions.
Come to Atlanta for a two-day workshop to get up to speed on the regulatory landscape, the latest reporting processes and complaint definitions and more.
The agenda includes:
- Discovering the similarities and differences among US, EU, and Canadian systems and their process flows and decision points
- Determining the function of QSR, ISO 13485:2016, ISO 14971:2019, and their national and regional variants
- Familiarizing yourself with multiple definitions of complaints and their implications
- Identifying the characterization of records and reports and how they support regulatory requirements
- Reviewing FDA Warning Letters and learning how to avoid their problems
- Recognizing when a design change triggers an updated regulatory submission
- Assessing the decisions and timelines for field actions