Case Study

Ensuring Excellence in Biocompatibility Compliance as per the new EU MDR Standards

Achieving Safety and Efficacy in Medical Devices through Biocompatibility Compliance
1-Aug-09-2024-12-03-31-7348-PM

BEP/TRA/BERSubmitted

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Tech Files Submitted to NBs

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Files approved by NB​

Background

Our client is a renowned German-based medical device manufacturer with a 150-year legacy of delivering solutions that enhance cleanliness, operational efficiency, and quality patient care. Their extensive portfolio covers critical therapy areas such as infusion therapy, diabetes care, surgery, orthopedics, neurosurgery, urology, and wound management.

However, ensuring biocompatibility compliance, particularly under the stringent requirements of the new EU MDR, presents significant challenges. These include rigorous testing protocols, navigating complex regulatory frameworks, and maintaining consistent product quality across diverse product lines to avoid adverse events.

Challenge

The client faced significant challenges due to increasingly stringent oversight by regulatory bodies, coupled with a lack of internal bandwidth and toxicological expertise. This situation hindered their ability to efficiently meet compliance requirements.

As EU MDR deadlines approached, the client needed to identify and evaluate alternatives to existing materials and processes to meet regulatory expectations and ensure product biocompatibility. This task required substantial time, investment, and resources, placing additional strain on their capabilities. Additionally, ensuring the safety and efficacy of alternative materials added complexity to their compliance efforts, necessitating thorough testing and validation.

Solution

Tata Elxsi facilitated a thought leadership team to develop customized, risk-based approaches that minimized testing and expedited time to market. Our multidisciplinary domain experts collaborated with the client to transition from a checkbox compliance approach to a comprehensive risk mitigation framework.

We conducted in-depth risk assessments and implemented targeted solutions to address potential issues effectively. Tata Elxsi ensured compliance with EU MDR and ISO 10993 standards by delivering detailed technical reports and guidance. Additionally, Tata Elxsi supported lab and supplier coordination, ensuring timely testing and streamlined supply chain processes, which ensured regulatory adherence.

2-Aug-09-2024-12-07-15-1435-PM

Impact

  • Achieved a 97% reduction in biocompatibility test samples, significantly lowering costs and optimizing resources.
  • Achieved successful first-time regulatory submissions through specialized gap analysis tailored to notified body requirements.
  • Strategically balanced budgetary constraints with extensive testing and evaluation requirements, ensuring efficient resource allocation.
  • Facilitated a seamless transition to MDR compliance, ensuring timely adaptation to regulatory changes.

Services rendered

Tata Elxsi

  • Biological Evaluation as per EUMDR and ISO 10993
  • BEP, BER, TRA Reports, CMR Evaluation
  • Detailed Raw Material Evaluation through Material Bibliography
  • Drug Device Interaction Studies
  • NB Deficiency Response Support​

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