Infographics related to Medtech
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We have the know-how to support your companion diagnostic (CDx) project through its entire lifecycle, from idea generation all the way through registration and postmarket. Regulatory requirements for CDx vary significantly by region. They must be aligned with a specific medicinal product (International Non-proprietary Name, INN) registration. This process necessitates dual expertise, we can manage the intricacies of CDx and their unique regulatory pathways in all major markets.
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Regulatory requirements for combination products vary significantly by region, and registration frequently necessitates a dual assessment approach. We can manage the intricacies of borderline products and navigate unique regulatory pathways in all major markets.
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Our highly professional and experienced regulatory affairs and compliance teams are available to provide support as required. Our team members’ experience includes Regulators, Notified Bodies and Industry covering a wide range of products.
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The Medical Device Regulation (MDR – (EU) 2017/745) and In-Vitro Diagnostic Regulation (IVDR – (EU) 2017/746) present a significant challenge for medical device manufacturers. Our highly professional and experienced medical device team is available to provide support as required. Our team members’ experience includes regulators, notified bodies, and industry and cover a wide range of products.