Engineering
Welcome to our Engineering Services at Apotech. As a trusted partner in the IVD industry, we offer specialised engineering solutions designed to meet the unique demands of healthcare innovation.
Engineering
Our Engineering Services encompass a comprehensive spectrum of essential processes crucial for creating, validating, and refining In-Vitro Devices. From meticulous verification and validation to rigorous usability testing and human factors analysis, our dedicated team is committed to ensuring the safety, efficacy, and regulatory compliance of your products. With a steadfast commitment to precision, innovation, and adherence to ISO 11137 standards, we are prepared to guide you through every stage of the design and development journey, from initial concept to successful commercialization.
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Featured case studies
Medical device CSV
Medical device CSV Introduction IVD manufacturer The client is an IVD manufacturer based in Europe. Although already ISO 13485:2016 certified, they were agnostic when it came to GAMP 5 and 21 CFR PART 11. They have 80 employees based over 2 sites in France. Apotech consultant: Apotech’s consultant coordinated 5 technicians, acting as project manager…