Client Background

• Client: A leading US based global medical aesthetic device company
• Industry: Medical devices
• Services: Enables physicians to provide advanced energy-based solutions for a broad range of medical aesthetic applications

Challenge

Some of the key drivers for the EU MDR remediation included:

• New products acquired due to M&A with different Quality Management Systems (QMS)
• The certificate expiration of each product family was different with a different Notified Body (NB)
• Each product had different maturity of technical files which needed to be remediated
• Surveillance audits by NB) threw up multiple non-conformities indicating weak areas in clinical evaluation and Post-Market Clinical Follow-Up (PMCF) based on MEDDEV 2.7.1 (European Medical Device Vigilance System)

A crucial first step was to establish a strategic regulatory and compliance plan with a proposal for how and what stages would be needed to evaluate the status of each medical devices’ compliance with EU MDR 2017/745 and to bring the product lines into compliance with EU MDR while still reflecting compliance with Medical Device Directive (MDD). A second challenge was to coordinate with the management to develop a business and regulatory strategy consistent with the remaining objectives of senior management. This included the consolidation of Intellectual property (IP) and manufacturing from a compliance planning perspective. Finally, the third challenge was to create a global offshore onsite working model to provide key regulatory and compliance/ engineering teams of SMEs (Subject Matter Experts). Their role was to develop and implement the compliance plan and processes involved against the newest ISO standards. This included plans for the first five product candidates (largest revenue producers) for gap analysis and remediation of all sections of the technical files (technical documentation) and clinical evaluation reports on a timely basis accompanied by complete harmonization and remediation of global QMS.

The customer made a strategic regulatory plan to consolidate product ownership due to tax and regulatory considerations and business supply line considerations, consolidate multi-country manufacturing locations, and decide on product continuity based on regulatory time lines and certification expirations or US FDA considerations and an ROI analysis. In addition, the customer wanted to explore the possibility of a consolidated notified body strategy for regulatory compliance by geography. As the situation of Notified Body (NB) got complex in terms of number of approved one and access to them, the MDR driven expectations and feedback from these NB became difficult to manage. The client needed Wipro to guide and consult them on NB strategy as well.

Solution

The customer’s goal was to consolidate IP ownership, manufacturing and product lifecycle management within the context of new product introductions to bring in near term and long term efficiencies. The company approached Wipro to look at these EU MDR gaps, assess other product families and come up with a detailed plan for remediation to achieve quicker time-to-market.

Wipro proposed a 3-phase approach for the assessment and remediation

The customer was previously not required to fulfill the medical device regulatory requirements. Hence, it did not have the adequate staff for regulatory, QMS, gap analysis, testing, remediation, and CER compilation and compliance. Further, the entire process required a complete harmonization and remediation of the multi-country QMS procedures. A global QMS was envisioned for all the sites and one notified body was established. A complete QMS harmonization was established and compliance with MDR for the technical documentation for 5 lead products was achieved.

From the EU MDR point of view, these products had been classified as non-medical aesthetic products in different geographies. New regulations had brought all these aesthetic Class IIb products under the same regulations and new requirements classified them as devices with a medical purpose.

The customer had acquired various QMS as part of their acquisitions strategy and wanted to harmonize all the QMS into a single global QMS. The proposed plan included remediation of 52 core global QMS documents which expanded to 108 over the course of the program. This included gap analysis of technical files and CERs for all medical devices across geographies and completion of the testing and remediation of all sections of the technical documentation over a nine-month time frame. This required coordinating the efforts of several team members across the global footprint by Wipro leadership and work task teams that included SMEs from Wipro and the customer. One of the biggest challenges was the interdependency between associated SOPs, work instructions and templates.

Business Impact

• QMS harmonization had to be prioritized so that MDR compliant procedures were in place to allow faster product remediation
• Wipro's EU MDR toolkit accelerated the gap assessment and remediation activities across all the five product categories
• New state of the art standards required special attention – cyber security, usability, laser standards, risk management, 62304/SDLC, sterilization, cytotoxicity, packaging, etc. There is improved clarity on applicable standards and guidance
• Failure of some of the key tests were closely monitored and mitigated quickly
• Leaks in DHF, test reports and technical files have been plugged

Key business outcomes included:

• Number of products covered for remediation: 5 Class 2b devices
• 5,000 pages of DHF on an average per product
• Number of gaps identified across 5 products: Around 700
• Number of CERs delivered: 5
• Redline and finalization of 5 IFUs and around 75 product labels
• Additional number of compliance tests performed: 20
• Number of new standards that were applicable: An average of 90 standards across 5 products
• QMS remediation: Remediated 108 documents which are SOP/WI/templates