The reference standards used by companies in the medical device sector are:
At a statutory level, compliance with harmonized European standard EN ISO 13485 guarantees conformity to all statutory requirements covering quality assurance systems (complete, production, product).
Environmental management systems (EMS) are certified in a voluntary context. The reference standard used is ISO 14001.
On a commercial level, conformity certification of an EMS is a major asset for obtaining access to the international market, submitting tenders and subcontracting.
For information on the LNE/G-MED certification process, see the section Obtaining certification