REGULATORY / QUALITY

Regulatory Affairs

Haselmeier has extensive experience in working with regulatory authorities and can provide support with device registration.

UPDATE
Certificates for the German manufacturing site:

  • Medical Device Directive 93/42/EEC, Part II (Download)
  • EN ISO 13485:2003 CMDCAS in Canada (Download)
  • EN ISO 13485:2012 + AC:2012 in Germany (Download)

 

Certificates for the Czech manufacturing site:

 

Certificates for the Indian manufacturing site: