Certifications and compliance

Certifications and compliance

Quality management: we are certified according to ISO 9001 (pdf, 504 KB) quality management standard as well as ISO 13485 (pdf, 297 KB), the specific quality standard for medical devices.

Health and safety: six of our sites are now certified to OHSAS 18001 standard.

Environmental management: most of our global operations are certified to ISO 14001 standard.

Our warehouses comply with ISO 9001 (pdf, 504 KB), ISO 13485 (pdf, 297 KB), Quality System Regulation (QSR), Good Distribution Practice Guidelines 2013/C 343/01 and local and regional regulatory requirements.

Many sites also fulfil QSR as well as local or regional regulatory requirements, including:

  • Medical Device Directive (MDD; 93/42/ EEC and 2007/47/ EC)
  • Biocidal Product Directive (BPD; 98/8/EEC)
  • Directive for Medicinal Products for Human Use (2001/83 for EEC)
  • QSR (21 CFR section 820)
  • Food and Drug Administration (FDA) Current Good Manufacturing Practices.

Contact us

You can contact our head office via the information provided below or by using the contact form. For contact information to local market offices, please refer to the company directory.

For product complaints or adverse events, please contact us using the Adverse event report form.



Mölnlycke Health Care AB
Box 130 80
SE-402 52 Gothenburg
Sweden

Visiting address: Gamlestadsvägen 3C

Phone: +46 (0)31 722 30 00


 

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