News
Other news
25.08.2011
Audit conducted by SGS United Kingdom Ltd.
In July 2011, the company was audited by SGS United Kingdom Ltd. with the aim of assessing the compliance of the medical device „Sterile eye drops” with the requirements of Directive 93/42/ЕЕС and of the quality system with the requirements of ISO 13485:2003.
The following certificates were granted as a result of the audit:
- Certificate of compliance with the requirements of Directive 93/42/ЕЕС (Annex II) for products of the type „Sterile eye drops”;
- Certificate of compliance with the requirements of ISO 13485:2003 for design and production of sterile eye drops;
- Certificate of compliance with the requirements of ISO 9001:2008 for design and production of sterile eye drops.
The received certificates of compliance are a major step toward enlarging the company portfolio with similar products.