EU MDR/ IVDR Implementation

Smart | Agile | Scalable

EU MDR & EU IVDR Compliance

EU MDR/ IVDR Implementation

Smart | Agile | Scalable

Trending

Trending

With the new EU MDR and EU IVDR, the industry is witnessing a dramatic increase in the cost of quality due to the high unpredictability and volume of work.

The massive change in the regulations has significant implications for all the global medical device companies operating in the EU nations. Businesses need to tackle the high volume of work within the stipulated timeframe while containing the cost of compliance and mitigating any business implications arising out of implementation delays.

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Martin Schauble
Martin Schauble
Martin Schauble

Martin Schauble

"Tata Elxsi has proven to be the right partner, bringing the right mix of technical expertise and program management skills. Together with Tata Elxsi, we are in the position to continue our innovation activities and adherence across Aesculap‘s product portfolio."

Vice President Abdominal and Cardio-Thoracic Surgery, Aesculap AG

Opportunities & Challenges

Opportunities & Challenges

Opportunities & Challenges

The healthcare industry continues to grapple with stringent regulations, pressures to retain profit, increase customer loyalty, and maintain brand value.

To reduce the cost of compliance and minimize associated risks, organizations need to adopt best practices and configure processes that ensure certainty and maximize confidence in transition. Given the ambiguous nature of the requirements, lack of legacy data, and the limited number of notified bodies, organizations need to implement measures to minimize stress on the bottom-line and have greater visibility into the overall transition expenditure.

Service Framework

EU MDR & EU IVDR Compliance
EU MDR/IVDR Assets
  • A cross-functional team of
    • Medical device design and development specialists (with expertise in therapeutic, patient monitoring, surgical, medical imaging devices)
    • IVD device design and development specialists (with expertise in point-of-care, molecular biology, immunology, clinical chemistry, hematology)
    • Biomedical engineers
    • Medical writers
    • Regulatory & quality experts
    • Biocompatibility experts
  • Expertise in assessment as per applicable standards (ISO, ASTM, CLSI, TGS guidelines, etc.)
  • Reusable checklists for accelerated gap analysis of QMS, performance evaluation, labeling, packaging processes, etc.
  • Repository of templates for technical file remediation (e.g., IFU, UDI, etc.)
  • Comprehensive training modules ensuring on-demand scalability

Differentiators

  • Centralized agile-based project management methodology ensuring predictable outcomes with pre-defined SLAs

  • Catalog pricing and outcome-based commercial model to support customers through the unpredictable variability and volume of activities 

  • End-to-end DHF remediation including drawing creation, testing, process validation, translation, etc., ensuring submission-ready dossier

Benefits to the Customer

  • Optimized compliance costs and greater visibility into overall transition spend

  • Centralized program management to foster cross-functional collaboration

  • Comprehensive remediation coverage and robust technical file creation with a reduced turnaround time

  • Improved agility to swiftly address any additional rework

Discover More

Ensuring Uninterrupted Sales Of Legacy IVD Devices in the EU Market
Case Study

Ensuring Uninterrupted Sales Of Legacy IVD Devices in the EU Market

Impact of EU IVDR on Key Compliance Areas
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Impact of EU IVDR on Key Compliance Areas

7 ways how the EU MDR is impacting the global medical devices industry
Blog

7 ways how the EU MDR is impacting the global medical devices industry

MDR/IVDR Program Management – Agile Way
Technical Whitepaper

MDR/IVDR Program Management – Agile Way

Decoding the New European Union In-Vitro Diagnostics (IVD) Medical Device Regulation 2017/746
Technical Whitepaper

Decoding the New European Union In-Vitro Diagnostics (IVD) Medical Device Regulation 2017/746

Unfolding the EU MDR through the Lens of a Remediation Partner
Technical Whitepaper

Unfolding the EU MDR through the Lens of a Remediation Partner

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