- 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
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.
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