Propel’s QMS, PLM, regulatory solution medtech

Propel’s QMS, PLM, regulatory solution medtech

November 18, 2020

Propel

https://www.propelplm.com/

Propel, the only product success platform built on the cloud, announced the availability of Propel for Medical Devices, a dedicated solution for Health & Life Sciences manufacturers that will streamline processes, lower costs, mitigate risk, and provide better patient outcomes. The solution includes two new regulatory capabilities that are natively integrated in Propel: Electronic Instructions for Use (eIFU), which allows medical device manufacturers to remain compliant with the EU Medical Device Regulation by automatically publishing and managing medical device instructions on publicly-available websites; and Global Product Registration (GPR), which simplifies commercialization by helping medical device manufacturers maintain access to each market that requires product registration. 

Propel for Medical Devices enables better product and service quality through closed-loop processes, mitigating potential issues proactively and in real-time. The platform natively integrates these Quality Management System (QMS) capabilities with GPR, eIFU, and the previously announced Digital FDA Medwatch 3500A reporting. As with all Propel capabilities, Propel for Medical Devices allows companies to design for quality and reduce compliance costs thanks to its single platform that includes both QMS and Product Lifecycle Management (PLM).

Tailored for medical device companies, Propel’s newest solution can better address the specific compliance needs of the industry, while helping companies connect their teams, improve product quality, and bring products to market faster. Advanced Sterilization Products (ASP), a global leader in developing innovative sterilization and infection prevention products, has partnered with Propel to deploy the solution within their organizations. “ASP relies on Propel for Medical Device to accurately and efficiently tackle one of the most labor-intensive and highest compliance risk areas: assessing all product complaints for reportability and digitally submitting to the FDA,” says Chanda Owens, VP Worldwide Quality at ASP. “Propel’s solution for Digital FDA Submissions helps us ensure all reportable complaints are accessed,  documented, submitted, and received by FDA with full reporting traceability.”

With Propel for Medical Devices, ASP is deepening its usage of the system. “We are also very excited to implement Global Product Registrations within Propel,” says Brent Lewis, IT Director, Quality, Compliance, and R&D Systems at ASP. “With the numerous country and region-specific requirements, it is challenging for companies to enter global markets, adhere to local standards, properly register devices, and keep those registrations up-to-date. Propel brings this visibility and tracking into our PLM and quality system. This gives visibility to our cross-functional product teams, and puts in place the proper controls for where we can sell and distribute our products.”

“Propel is thrilled to have ASP partner with us on this launch,” said Ray Hein, co-founder and CEO of Propel. “We are uniquely suited to help medical device companies exceed their product quality, innovation, and compliance goals. Our product success and eQMS platform is the most flexible and efficient solution for health and life sciences manufacturers who believe company-wide collaboration delivers the best products and customer experience.”