Tel. (+45) 4499 8444
Fax. (+45) 4499 1544


Quality is a must. Not just product quality but quality in everything we do including, servicing, the way we communicate and the way we enter into agreements. We make every effort to deliver the very highest quality in all these areas.

During the development process, we can provide support for or handle patent conflicts, literature studies, project management, risk analyses, product approvals and manufacturing documentation.

Tonica Elektronik A/S is DS EN ISO 13485:2003 and AC:2007 certified by DGM (Danish Medical Devices Certification).

Where relevant to your product, we are also certified in the following areas:

  • Annex II: Full quality assurance (MDD EC Directive 93/42/EEC) CE marking responsible
  • FDA approvals (US)
  • CMDR approvals (Canada)

Other national approvals.