SANTA CLARA, Calif., March 5, 2020
Propel, the only product success platform built on the cloud, today announced the introduction of Digital FDA Submissions, our newest product innovation for medical device manufacturers subject to FDA reporting requirements. Propel’s Digital FDA Submissions allow medical device manufacturers to electronically create, submit and track progress with MedWatch Form FDA 3500A submissions directly through the Propel platform. The new capability streamlines compliance with FDA 21 CFR Part 803 Medical Device Reporting and integrates all information exchanged with existing audit trails.
Companies can now complete a new Form FDA 3500A directly in Propel, leveraging product, customer and quality information that already exists in the platform. Once completed, companies can submit the form electronically to the FDA through Propel, which records proof of submission. Propel then records all acknowledgments and other communications with the FDA as proof of reporting compliance.
Medical device manufacturers typically rely on manual systems such as fax or postal mail when submitting adverse events to the FDA. These methods, although the norm, are slower and less reliable in recording and time-stamping events accurately. Propel’s cloud-based QMS helps Medtech organizations improve process efficiencies and audit readiness by submitting the MedWatch 3500A adverse event form electronically while tying and recording the proof of submission directly to the product record for future audits.
“Propel is fast to deploy, easy to use and has the flexibility to support our processes in a single solution,” said Brent Lewis, Director, Enterprise IT Quality and Compliance Systems at Advanced Sterilization Products. “Electronic adverse event reporting is the latest advance in Propel offering end to end capability connecting early design to customer feedback and regulatory reporting. This enables incredible insight intelligence and ensures compliance for our business.”
“With medical device manufacturers facing extreme competition in pursuit of higher quality, safety and increasing customer demands for improved product features, it is critical to tie product, customer and quality data together,” said Ray Hein, CEO of Propel. “Propel’s Digital FDA Submission capabilities help regulatory and quality teams easily and efficiently manage the entire process with the FDA,” he further added.
Increasing product complexity, service-based models and globally interconnected value chains need to be carefully managed to ensure better patient outcomes. Propel’s product success platform seamlessly connects all product, customer, quality and service records to provide a true closed feedback loop that helps companies get products to market faster, maximize customer satisfaction and comply with all regulatory agencies.
Propel helps companies achieve product success by connecting the people, systems, and processes needed to deliver products from concept to customer. Our configurable platform is the single source of product truth for your entire value chain, including sales, service, and partners. Secure and transparent collaboration enables you to get products to market faster while maximizing customer satisfaction and meeting local requirements needed to compete globally.
Propel is built on Salesforce, the industry's top-rated cloud SaaS platform, and our solution incorporates all the capabilities of its modern cloud infrastructure. Salesforce's multi-tenant architecture is future-proof, ensuring Propel will always be the next generation product success platform. For more information, visit www.propelplm.com.