CE Certiso Ltd. has been established in 2011 to perform certification and CE conformity assessment in the field of manufacture and distribution of medical devices.

As an accredited certification body we perform quality management system certification according to standards EN ISO 9001:2015 and EN ISO 13485:2016 in accordance with the requirements of ISO/IEC 17021-1:2015.  Our certification activity is performed by multilingual auditors with several years of experience.

As a notified body we perform conformity assessment procedure of all classes (I.s, I.m, II.a, II.b and III.) of medical devices in the fields of MDD, IVDD and AIMD. Our notification and the designation areas and the possible certification routes can be found on the NANDO website.

During our conformity assessment activity, we also take into consideration the regulation of Code of Conduct for Notified Bodies under Directives 90/385/EEC and 93/42/EEC and the Commission Recommendations of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU). At least once in every 3 years we perform unannounced audits.

CE Certiso Ltd. is aim to make its activity quickly and reliably. For the best cooperation between our clients and our company, we give particular attention to impartiality and confidentiality. Our liability insurance covers our activities in all countries of the world.

Our company is a member of Hungarian Standards Institution, we take part in the standardization activity.

Fields of our notification:

  1. ISO 9001 and ISO 13485
  2. MDD, AIMD and IVD