We accelerate
what you
Regularity Affairs Consultancy
reate
HI THERE. WE’RE CREATE REGULARITY AFFAIRS CONSULTANCY
We’ll help you set clear priorities, integrate them with your bigger goals, and ensure your organization is ready to tackle challenges.
At Create, we specialize in crafting strategies that align with your unique needs.
Tailored Regulatory Strategies for Your Business Success and Growth.
EU-Medical Device Regulation
Bringing years of expertise, our EU-MDR consultancy excels in creating MDR-compliant technical files from scratch, ensuring strict adherence to the regulations of the European Union Medical Device Regulation. Rely on us to adeptly navigate complexities, enabling your medical devices to enter the European market confidently.
EU-In Vitro Diagnostics Regulation
With a wealth of experience, our consultancy excels in composing performance evaluation reports in alignment with the EU-IVDR.
Our adept team ensures meticulous preparation, guiding your In Vitro Diagnostic Devices through the complexities of European regulatory requirements.
Health Canada-Medical Device Application
Leveraging our extensive expertise, our consultancy specialises in crafting Medical Device License Applications for Health Canada.
Our capable team ensures meticulous preparation, guiding your devices through the intricacies of Canadian regulatory requirements.
US-FDA| 510(k) and PMA Submission
Bringing years of expertise, our consultancy specializes in crafting 510(k) and PMA submissions for the US FDA. Our adept team ensures meticulous preparation, guiding your medical devices through the intricate pathways of FDA regulations. Count on us for successful market entry in the United States.a
OUR MISSION
At Create, we specialize in crafting strategies that align with your unique needs.
We will be exhibiting at RAPS Euro Convergence Brussels 2025
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May 13-16
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Meet us at Booth TB 9
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We will be exhibiting at RAPS Euro Convergence Brussels 2025 · May 13-16 · Meet us at Booth TB 9 ·
Join our Regulatory Augmented Intelligence Performance Study
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Join our Regulatory Augmented Intelligence Performance Study ·
ARTICLES FOR EXCELLENCE IN REGULARITY
