CanadaBuys #AB-2026-00958

Award for Regulatory Consulting and QMS Development for Wearable Medical Device

This award notice details the University of Calgary's selection of Aetherium Regulatory Consulting LLC (ARC) for specialized regulatory consulting and Quality Management System (QMS) development services supporting a novel wearable medical device. - Government Buyer: - University of Calgary, Alberta, Canada - Clinical Neurosciences research program - OEMs and Vendors: - Aetherium Regulatory Consulting LLC (ARC) (sole supplier and service provider) - Products/Services Requested: - Regulatory consulting services - Quality Management System (QMS) development - Clinical trial review - Post-market support - No specific products, part numbers, or purchase quantities are listed - Unique or Notable Requirements: - ARC identified as the only supplier capable of meeting all technical, regulatory, and operational requirements - Services are integrated to support the design, development, regulatory strategy, and submission of a novel wearable medical device - Emphasis on experience in biotech and regulatory consulting (over 10 years) - No other OEMs or product manufacturers are mentioned

Description

The University of Calgary intends to award a master service agreement to Aetherium Regulatory Consulting LLC for specialized regulatory consulting and Quality Management System development services. These services will support the design, development, regulatory strategy, and regulatory submission of a novel wearable medical device under the Clinical Neurosciences research program. Aetherium Regulatory Consulting has over 10 years of biotech and regulatory experience and offers a wide range of services including regulatory consulting, clinical trial review, and post-market support. The proposal is deemed technically suitable and financially feasible for the full scope of required services, and Aetherium Regulatory Consulting is understood to be the only supplier able to meet all technical, regulatory, and operational requirements in an integrated delivery model.

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