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Certification for quality and compliance

Trelleborg Sealing Solutions considers quality and standards to be of prime importance to the success of our customers. As such, we have invested heavily in acquiring approvals both for our locations and materials.

Location certifications

All Trelleborg Sealing Solutions manufacturing facilities are certified to worldwide quality standards in addition to our own stringent quality requirements:

  • ISO 13485
  • ISO 9001

Material certifications

Trelleborg Sealing Solutions manufactures products from a wide range of materials, with compliances to a broad range of industry standards:

  • FDA 21 CFR part 177
  • EU Reg (EC) 1935/2004
  • 3-A SSI Standards 18-03 & 20-25
  • USP Class VI
  • NSF 51 & 61
  • ISO 10993-5 / USP 87
  • Bundesamt für Risikobewertung (BfR)

Read more about industry standards

Device and Drug Manufacturing Licenses

Two locations have licenses granted by the State of California for the manufacturing of medical devices and the manufacturing of drugs (for combination products).


For more information, or to see the certificates, please contact your local Trelleborg Sealing Solutions marketing company .

Local Contact

To speak to a local healthcare & medical specialist, call the number listed for your region:

Americas
+1 310 921 4170

Asia
+886 9 3098 2646

Europe
+49 (0) 711 7864 536

Contact

Digital Tools

News

Trelleborg Advances Contract Manufacturing Services for Drug-Device Combination Products At MD&M West 2017, Trelleborg Sealing Solutions successfully highlighted its contract manufacturing services for delivering drug-device components – the combination of any two or three products categories: medical devices, drugs and/or biologics.

#TrelleborgThinkTank Sparks Innovation at MD&M West 2017 MD&M West 2017 is the perfect venue for attendees to share ideas and encourage innovation using the hashtag #TrelleborgThinkTank, an exciting initiative from Trelleborg, the global leader in engineered polymer solutions.

Trelleborg Demonstrates Rapid Medical Device Prototyping and Enhanced LSR Technology at MD&M West 2017 MD&M West 2017 Booths 1605 & 2818 will serve as the perfect platforms for Trelleborg Sealing Solutions to emphasize its rapid medical device prototyping that facilitates bringing medical devices to market faster and helps to drive innovation.

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