From 1997 Sanatmetal Ltd. is licensed to use the CE mark for its whole product range. From 2005 Sanatmetal operates an integrated management system which includes the quality management and environment management systems.
The commitment toward quality and continuous improvement is also proved by winning the National Quality Award in small companies category.
All processes of the company including product development, quality management, production, packaging process, handling of partners comply with the requirements of the ISO 13485, ISO 14001 standards, Medical Device Directive 93/42/EEC together with the 4/2009 (III.17.) order of Ministry of Health, besides meeting the relevant legal requirements.
The Notified Body of the Sanatmetal Ltd. is the British Standard Institution (Notified Body No. 2797) which regularly controls and supervises the whole management system twice a year. Furthermore, product development and the cleaning process are controlled on special technical, microbiological and environment management audits. Our environmental management system is certified by CERTOP.
In 2008 the company obtained the FDA registration for intramedullary products. All the related activities are managed by Organix Llc in the USA.
The FDA approval is downloadable here: FDA approval.pdf
The Notified body of SanatSwing knee prosthesis and the Pannon and Sanat hip prosthesis systems is the EMKI (Notified Body No. 1011). According to the valid new regulation this product range belongs to class III and its authorization process was carried out accordingly.
The printable version can be downloaded here: Certificates.pdf
In 2014 ANVISA audited the activity and quality management system of Sanatmetal and the compliance with Brazilian rdc16/2013 GMP regulations.,The printable version can be downloaded here: ANVISA Certificate.
List of certificates
- Anvisa Certificate
- CE 01821
- FM 38375
- ISO 13485_2016 - 144860-19-02-28-ENG
- EC Design examination certificate - CarBulat
- EN ISO 13485-2016
- 5-701-204-1111_EMKI 1343
- EC Design-Examination certificate - Swing
- 5-701-204-1111_EMKI 1342
- EMKI HIP-KNEE Full quality assurance system EC certificate rev2
- ISO 14001 certificate
- EMKI hip design examination certificate