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Certificates

Wellspect™ and compliance with Medical Device Legislations

As legal manufacturer and distributor of medical device products Wellspect HealthCare, complies with many regional and national laws, guidance as well as international standards.  For instance, we comply with the European Medial Device Directive (MDD, 93/42/EEC as amended). The CE-mark on our devices is the proof of MDD compliance. We have recently updated our internal quality management system with the aim to comply with the new European Union law, i.e. the Medical Device Regulation (MDR, 2017/745, as amended) which will replace the MDD in middle of May 2021. Therefore, the CE-mark will eventually instead represent MDR compliance. 

Although compliance to European directive and law plays an important role also for many countries outside Europe, we also comply with national laws in many other countries where our medical devices are registered. A few examples:  the US Quality Systems Regulation (21 CFR section 820), governed by the Food and Drug Administration (FDA), medical device regulations in Canada, Australia, Brazil, South Korea, China etc. 

External Quality Assurance and Certificates

Our company is regularly audited by Notified Bodies, who are reviewing our production facilities, quality management system and technical documentation, when needed, to ensure we comply with external laws, regulations, and international standards. Notified Bodies are independent organisations that have received a mandate by national authorities, to perform audits according to their competence area.  As evidence for our compliance, different certificates are issued by Notified Bodies. The certificates may have different period of validity, depending on their scope, but common for all is that regular surveillance audits will be performed during the validity period to reassure the auditors we are still in compliance. 

Certificates been issued by the Notified Body for our environmental management system and for our quality management system, as well as our technical documentation for our medical devices. While we are awaiting an audit to prove we comply with the MDR, the MDD certificates are still valid. 

  • ISO 13485:2016
  • ISO 14001:2015
  • MDD 93/42/EEC Annex II
  • MDD 93/42/EEC Annex V