AARQK Consulting

AARQK Consulting is a leading business consultancy specializing in delivering premium clinical regulatory expertise to support MDR / IVDR certification projects and medical device lifecycle activities. AARQK Consulting works directly with manufacturers, start-ups, and investors, as well as established consultancies and CROs, providing solutions for project-specific or interim limitations in specialist clinical regulatory expertise and capacity. Located in HAARLEM, NL, AARQK Consulting helps clients leverage in-house experience in successfully supporting the 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 Consulting excels in generating high-quality clinical technical documentation for regulatory submission, as well as providing clinical regulatory strategy and competitor/market analysis to inform internal decision-making in device development and market entry. AARQK Consulting 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 clinical evaluation, post-market surveillance, and clinical studies.

AARQK Consulting is committed to 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. We invite the manager of AARQK Consulting to create a customized and exclusive company showcase and product listing on our platform to further enhance its market presence.