Certification for Quality and Compliance in the Healthcare & Medical Industry
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.
All Trelleborg Sealing Solutions manufacturing facilities are certified to worldwide quality standards in addition to our own stringent quality requirements:
- ISO 13485
- ISO 9001
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)
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 .