Regulatory / Quality
Regulatory Affairs
Haselmeier has extensive experience in working with regulatory authorities and can provide support with device registration:
- Class I, IIa and IIb devices within EU
- Combination products
- Compliance with FDA Quality System Requirements
- 510 (k), Master File
- Japan PAL
| 1993 | Certification to ISO 9001 |
| 1996 | Certification to ISO 9001:1994 |
| 1999 | Certification to ISO 9001:1994 and EN 46001:1996 |
| 2002 | Certification according Part II. 3 Medical Devices Directive 93/42/EEC Certification to ISO 13485:1996/ ISO 9001:1994 |
| 2005 | Certification to ISO 13485:2003 Re-Certification according Part II. 3 Medical Devices Directive 93/42/EEC |
| 2008 | Re-Certification to ISO 13485:2003 Re-Certification according Part II. 3 Medical Devices Directive 93/42/EEC Certification to ISO 13485:2003 CMDCAS |
| 2010 | Certification to ISO 13485:2003 + AC:2007 in Czech Republic |
- CE Certification by TÜV SÜD Product Services
- Suppliers qualified according to international standards
- Comprehensive component, process and product validation