R.R. Donnelley & Sons Company (RRD) has a new solution designed to streamline the product recall communication process for medical device companies. Seamlessly integrating RRD’s highly refined capabilities in content creation, production management, and multichannel distribution, this solution aims to ensure end-to-end support throughout the complex medical device recall notification process.
According to Sedgwick, a leading global provider of technology-enabled risk, benefits, and integrated business solutions, FDA Class 1 recalls hit a 15-year high in 2022. With the increasing focus on patient safety and regulatory compliance, the need for immediate and effective communication during a recall is essential.
“The process to get a recall notice in the hands of the right person at the right time is complicated and urgent,” says Ken Gammon, senior vice president, RRD Healthcare Solutions. “Our solution removes a significant amount of the burden that medical device companies face in developing a tailored message, complying with regulations, and error-free delivery.”
HIPAA and SOC II compliant, this solution for medical device recall notification leverages a multi-location production network for speed and scale. Additional features of this solution include:
- Recall-specific content platform
- Proprietary automated fulfillment process
- Response capture platform (i.e., reply mail, FAX receipt, web capture, and call center)
- Multichannel distribution (i.e., print, email, FAX)
- White glove production management service
According to John Pecaric, chief operating officer at RRD, “RRD’s ability to streamline the communication process through automation and digital production of the recall notices — including integrating shipping labels with custom envelopes — will help our clients react with greater efficiency without having to compromise quality, compliance, or the safety of patients or members.”
For more information about RRD’s recall notices solution for the medical device industry, visit www.rrd.com/recall-notices.