Certificates
- EN ISO 13485:2016 | pdf | 147 kb
- EN ISO 13485:2016 MDSAP | pdf | 139 kb
- EC Certificate - Annex II | pdf | 985 kb (extended until 2027-12-31 and 2028-12-31, respectively)
- Extension Letter EC Certificate | pdf | 176 kb
- MDR Quality Management and non-implants | pdf | 188 kb