THE SOLUTION
Joining MMI in 2018, Mauro Ercolani, Vice President of Quality and Regulatory Affairs, saw the company rapidly evolving. He immediately recognized the need for a PLM system to successfully meet compliance requirements and expand product capabilities. This would give the company a centralized location to manage engineering changes, bills of materials (BOMs), product documentation, and the ability to streamline collaboration between internal teams and external partners.
Upon joining the company, Mauro suggested Arena. His recommendation was based on Arena’s understanding of modern technology companies, especially when it comes to complex products and the compliance requirements of medical devices.
There was unanimous support for the recommendation, especially from MMI’s CEO who has significant experience with the software and a strong desire to implement it. Not only was Arena a proven cloud solution for medical device companies, but the system also provided a unified platform for PLM and quality management. Mauro said, “To me, Arena was the right move, a fundamental choice because any company that manages sophisticated products cannot live without PLM.”
Designed to be configured and deployed fast, Arena’s cloud-native PLM and QMS solution provides MMI and their supply chain partners with a business-ready application that can be accessed anytime and anywhere. “I was pleased to learn Arena’s philosophy to configure versus customize the system,” said Zeno De Luca, Arena Administrator for MMI. “In my experience, customizing a system can be difficult and time-consuming. The configurability of Arena allows me to focus on critical work and ensures seamless product updates.”
With Arena, MMI has been able to consolidate the product configuration across various systems, eliminating the need for paper-based processes. Arena’s cloud-native platform enabled the company to scale its Arena system from item and BOM management to change management, document management, and training management. “At the moment, these processes are successfully managed through Arena. We are excited about the opportunity to continually discover additional system capabilities that can benefit us,” explained Mauro.
With roughly 50 training plans in place using Arena Training Management, MMI can efficiently meet training requirements for compliance. The company can ensure training on all their technical documentation such as device master records (DMRs) and operating instructions to help eliminate nonconformities, CAPAs, and complaints, so any actions that need resolution can be assigned to the right teams or groups.
Selling their products globally means MMI must comply with European (EU MDR) and U.S. FDA medical device regulations, as well as any country where the company wants to do business. When it comes to providing necessary process controls for compliance and connecting quality processes to the product BOM for maximum visibility and traceability, Mauro said, “Going from research to validation to production, we have tailored the workflows of the change orders so that they match the regulatory requirement, and we keep the burden for the user at the minimum possible level while keeping full compliance with the regulations.”
Arena Validate has helped MMI meet FDA 21 CFR Part 11 and Part 820 directives for software validation by validating Arena’s applications against predefined guidelines such as change and document management, design controls, DHFs/DMRs, electronic signatures, and quality management. Zeno said, “With Arena, we have a validated system that allows us to comply with regulatory body directives. We don’t need to spend time and money validating the system, it’s already done.”
