We are here for you every step of the way. With our support and advice, you can be confident of meeting your regulatory requirements right from the start.
Per ISO 13485: 2016 clause 8.2.4 and 21CFR 820.22 a Medical Device Manufacturer’s Quality Management System must be audited in accordance to a documented procedure.
The benefits of an audit performed by experts help adapt new and often better-quality solutions and helps circumvent old and insufficient practices.
BioReg experts can perform an Internal Audit to allow a balanced audit of your Quality Management System.
In addition to Internal Audits, BioReg can audit your suppliers or potential suppliers on your behalf.
BioReg has experienced auditors of different professional backgrounds who can audit your distributor, importer, raw material supplier, contract manufacturer, sterilization, or packaging provider.
For more information, please contact the BioReg team.
In order to inquire about our services or ask for immediate regulatory advice for your product, contact us.