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Quality Statement

Biocoat is committed to operating in accordance with all applicable regulatory and customer requirements in order to provide customers with products and services of the highest quality while operating under an effective and compliant Quality Management System that drives continuous improvement through quality objectives.

Biocoat Quality Policy provides a framework for establishing the objectives, policies, and procedures that comprise our ISO 13485:2016
certified Quality Management System
. Driven by top management, compliance with our quality systems, customer requirements, and applicable life science regulations is an organizational priority for all Biocoat associates.

Certifications & Qualifications

Biocoat’s HYDAK® coating development and manufacturing meets the highest standards. Quality controls (QC) are conducted in strict conformance with cGMP regulations and Biocoat is ISO 13485:2016 certified.

Let’s Connect

Our team of engineers and clinical experts would be glad to have a discussion about your project and its requirements.
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