Regulatory / Quality

Regulatory Affairs

Haselmeier has 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

Quality Management

Haselmeier's Quality Management System has been certified by TÜV SÜD Product Services and meets the statutory and regulatory requirements of all major authorities. Our internal quality goals will fulfill the strictest criteria of our pharmaceutical partners.

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

CE Certification by TÜV SÜD Product Services
Suppliers qualified according to international standards
Comprehensive component, process and product validation