Quality

biotech prodBohus BioTech meets the requirements of the Medical Device Directive (MDD 93/42/EEC) and EN ISO 13485. We also hold a GMP manufacturing license issued by the Swedish Medical Products Agency. Our quality system is reviewed and improved on a regular basis in order to maintain compliance with our quality objectives and to meet regulatory and customer requirements.

Third-party audits are performed regularly by the Swedish Medical Products Agency, as well as by the notified body, mdc medical device certification GmbH, CE 0483.

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