Cqura (see·cura) is a London-based life sciences consulting firm specialising in offering comprehensive regulatory, quality, and clinical advisory services to medical technology manufacturers. We guide our clients through every phase of the medical device development process, ensuring regulatory compliance and driving market success.
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Our Services
Regulatory
Our medical device regulatory services guide manufacturers through the complex regulatory landscape, ensuring compliance and market approval.
We offer tailored solutions for regulatory strategy, classification, submissions, gap analysis, and adherence to global standards such as FDA regulations, EU MDR/IVDR, UK MDR, EU AI Act and EU Battery Regulations—helping compliance throughout the product lifecycle.
Quality
Our quality management services help medical device manufacturers build and maintain compliant quality systems, including ISO 13485 and FDA QSR.
We support the design & development of QMS, process optimisation, risk management, internal audits, and documentation, ensuring product safety, efficiency, and continuous improvement—helping clients meet regulatory requirements and deliver high-quality products to market.
Clinical
Our clinical services provide advisory support to medical device manufacturers to gather the clinical evidence needed to ensure safety, effectiveness, and regulatory compliance.
We offer support in clinical strategy, evaluation plans, medical writing, clinical investigations, and post-market follow-up. Our expert team ensures you navigate complex regulatory requirements and achieve successful product approval across global markets in a timely manner.