Certification

Product must carry the CE-mark to be permitted for sales in the EU. Additionally, an increasing number of other markets around the world require CE marking on medical devices.

Presafe offers certification services of products and management systems based on major international standards including the Medical Device Directive, IVD Directive, Certification according to the Canadian Medical Device regulations – CMDCAS, IVD directive, ISO13485 certification and ISO9001 management system certification for medical devices.

Presafe provides:

  • Technical documentation/file review or design dossier assessment
  • Production quality assurance equivalent to ISO 13485 (excluding design) according to Annex V
  • Full quality assurance equivalent to ISO 13485 according to Annex II
  • EC verification according to Annex IV
  • Guidance, interpretation and training related to the relevant directives for your products.

Technical documentation review and design dossier assessment typically take place at Presafe´s premises while quality system assessments are carried out at the customers’ sites. For more information, please see under Medical Regulations and standards.

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