Client Background
- Client: A Fortune 500 American healthcare company
- Industry type: Medical equipment
- Products and Services: IV solutions, premixed drugs, infusion pumps, and administration sets; parenteral nutrition products; anesthesia; drug formulation and pharma partnering; peritoneal dialysis products; hemodialysis products; continuous renal replacement therapy
- Geography: Business distributed across North America, Latin America, Canada, Europe, APAC
Challenge
Medical device companies operating in European markets must adhere to stringent EU MDR regulations and submit detailed compliance-related information to EUDAMED (European Databank on Medical Devices). Any deviation can result in non-compliance and regulatory actions. Our customer, a major medical device manufacturer with millions of products across multiple classes of devices, was experiencing the following challenges:
- Tracking and managing the ever-increasing number of regulations and standards across geographies with stringent timelines
- Time and cost associated with process and information required for compliance was significant and increasingly demanding more involvement from the business; the cost of non-compliance was greater
- New regulations and long regulatory approval cycles delayed time-to-market
- Need for compliance reporting and e-signatures to support FDA 21 CFR and UDI/BUDI
- Submission of documentation to EUDAMED spanned multiple departments depending on the class of the product
Solution
Wipro implemented a product-centric enterprise Digital PLM system to manage the EU MDR processes, including data collection governance, tracking, reporting, automated submissions, and periodic reviews. Key features of solution implemented by Wipro include:
- Unified solution automated and enforced design control process
- Designated PLM as the system of record for Design History File (DHF) management and Device Master Record (DMR) management
- Established PLM as the system of record on products, policies, procedures, and documents
- Implemented BUDI management, periodic reviews, EUDAMED submissions tracking, and schedule management in PLM