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Quality Statement

Biocoat is committed to providing customers with products of the highest quality while operating under a QMS that drives continuous improvement. Biocoat is committed to operating in accordance with domestic and worldwide regulations for medical device companies.

The Quality Policy provides a framework for establishing and reviewing quality objectives. The Quality Policy is periodically reviewed to determine its suitability, and consequently, any improvements necessary to maintain to date good business relevance. Quality Policy and regulatory compliance are reinforced through regular training on quality assurance and regulatory compliance subjects. Training shall be documented and shall be kept current. It is the responsibility of all employees to ensure that their training and training records remain current.

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.


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