We're excited to announce that our Director of Recall Business Development, Hillary Medina, will be speaking at the AdvaMed's Device Complaints, MDRs, and Reports Workshop in Washington, DC on Tuesday, May 23-24, 2017.
Novasyte partners with med-tech companies, offering outsourced contract clinical, field technical and recall teams and services. Our cloud-based, S.M.A.R.T. Recall Program is an integrated, software and service-based solution to address the increasing challenges med-tech companies face when managing a recall. Our platform tracks every activity in real-time, including mock recalls, plan development, consignee notification, virtual or field-based product remediation, warehousing, and ongoing reporting.
Hillary's presentation, titled ""Communication Strategies for Recalls and Other Field Actions", will address the questions outlined below.
- Who should be responsible for communicating with the FDA?
- What should you keep in mind when developing a internal communications plan?
- What customer and other outside communications are necessary?
- What should you keep in mind when developing a field team communications plan?
- What documentation needs to be included on the notification letter?
- What is an effectiveness check?
- How should you write your recall correspondence?
- How do you determine that your recall is completed?