AARQK Consulting

AARQK is a boutique medical device consultancy, delivering premium clinical regulatory expertise to support MDR / IVDR certification projects and medical device lifecycle activities. AARQK works directly with manufacturers, start-ups, and investors, and as a functional service partner with established consultancies and CROs, providing solutions for project specific or interim limitations in specialist clinical regulatory expertise and capacity. Clients benefit by leveraging AARQK’s in-house experience in successfully supporting registration of both legacy and novel devices under the MDR and IVDR, including stand-alone and embedded software, imaging, invasive, implantable, and active devices, with intended uses in ENT, H&N / CNS, dental, oncology, ophthalmology, cognition, rehabilitation, endocrinology and wound healing indications. AARQK is an expert in generating high-quality clinical technical documentation for regulatory submission, as well as clinical regulatory strategy and competitor / market analysis to inform internal decision-making in device development and market entry. AARQK is a specialist in high risk and advanced devices with novel features. Clinical technical documentation preparation services, include de novo writing and remediation of existing documentation to satisfy regulatory requirements for: (1) clinical evaluation, such as clinical / performance evaluation (plans, reports), systematic literature searches (protocols, reports) (2) post-market surveillance, including post-market surveillance plans and reports, period safety update reports, regular monitoring activities (3) clinical studies, including pre-market clinical investigation and post-market clinical follow-up (plans and reports) AARQK is uncompromising in employing state-of-the-art approaches consistent with MEDDEV2.7/1 rev4, IMDRF, and MDCG guidances, as well as relevant international standards and industry best practices, to ensure compliant and high-quality deliverables.