Bioseal Quality

bioseal-iso13485-certified-header-banner-v1.gifBioseal is dedicated to continuously improving the performance and quality of its products and services to meet customer requirements and surpass expectations with custom packaging, sterilization and distribution services.

Bioseal is compliant with FDA 21 CFR Part 820 and ISO 13485:2016 certified for design and manufacturing of medical devices. Bioseal maintains an innovative Class 7 cleanroom and associated controlled environments that comply with ISO 14644. Bioseal has performed extensive validations with both Ethylene Oxide and Radiation Sterilization processes, in accordance with ISO 11135 and ISO 11137. Our quality team at Bioseal ensures that products are manufactured at the highest level of quality and certified to required specifications.

Bioseal offers quality engineering services to assist with product development, process, sterilization and packaging validations; in order to facilitate safe and efficient product entry into the market. Our quality management system is routinely audited by our ISO registrar; in addition, internal, external and customer audits are conducted frequently to maintain compliance with ISO 13485:2016 (See our Certificate).