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EU MDR/IVDR Consultants

In the pharmaceutical and medical device industries, regulatory compliance is an ever-growing challenge.

Explic8 specialises in regulatory affairs for these industries, having helped leading organisations across the globe to achieve and maintain compliance while driving business and financial outcomes.

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Achieving compliance, driving results

  • EU MDR 2017/745 Implementation & Compliance
    Explic8 has the knowledge and experience to help you overcome the hurdle of achieving and maintaining EU MDR compliance. Leveraging our extensive expertise, we help you navigate the challenges to ensure you have effective, profitable operations aligned to EU MDR.
  • EU IVDR 2017/746 Implementation & Compliance
    The transition to IVDR from IVDD will undoubtedly be complex and time-consuming,and time is running out. Explic8 can help you develop and implement a realistic road map, from pinpointing the steps to transition to identifying and mitigating risks and tracking progress.
  • Portfolio Analysis
    We take a practical approach to portfolio analysis, determining risks, areas of non-compliance and opportunities to make sure you derive maximum value and remain compliant.

Don’t take our word for it

We’ve helped organisations across the globe to achieve a variety of strategic outcomes. From helping a leading medical device company to achieve financial outcomes and increase its share price to driving record performance for a luxury goods company, Explic8 has a proven track record.

Read Client Case Studies