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

Business Impact

Wipro enabled seamless tracking of EU MDR submissions in the PLM system, thereby eliminating manual efforts and avoiding chances of non-conformance. Other benefits included:

• Timely and full data submissions to EUDAMED for EU MDR compliance
• Improved operational efficiency
• Improved ability to support FDA audits
• Shared best practices and reuse of data
• Reduce cost for change management
• Better and faster impact assessment due to change