ISO 9001:2015
Quality Management System
Covers design review, process control, inspection, and continuous improvement across all manufacturing processes.
ISO 13485:2016
Medical Device QMS
Compliant for medical-grade silicone and rubber components. Includes risk management and design controls per MDR requirements.
FDA Compliant
21 CFR 177.2600 / 1210
Silicone and rubber compounds meet US FDA food-contact and medical-use regulations. Master file available on request.
LFGB Certified
BfR Recommendations (EU)
Meets German BfR (Federal Institute for Risk Assessment) recommendations for food-contact materials. EU market ready.
REACH Compliant
EC 1907/2006 Registration
Full SVHC (Substance of Very High Concern) declaration. No restricted substances above threshold levels in any compound used.
RoHS Compliant
EU Directive 2011/65/EU
Six restricted substances tested and below limits. Declaration of Conformity (DoC) provided with every shipment to EU.
UL94 V-0 Rated
Flammability Standard
Flame-retardant silicone grades available that achieve UL94 V-0 rating for electronics and electrical applications.
IATF 16949 Aligned
Automotive Quality
Our automotive production line follows IATF 16949-aligned processes including PPAP, SPC, and APQP methodologies.
NSF Certified
Food Equipment Materials
NSF/ANSI 51 certified silicone compounds available for food equipment and drinking water system applications.
Which Certifications Apply to Your Industry?
- ISO 13485: Medical device QMS compliance
- FDA 21 CFR 177.2600: Medical-grade silicone approval
- ISO 10993: Biocompatibility testing (cytotoxicity, sensitization)
- USP Class VI: Plastics suitable for medical use
- GMP / Cleanroom: Class 100 cleanroom available for LSR medical parts
Automotive
- IATF 16949 aligned: Automotive quality management
- PPAP Level 1-3: Production Part Approval Process
- SAE J200 / ISO 143-1: Rubber material classification
- NACE MR0175: Sour gas compatibility (oil field)
- VDA 6.3: Process audit capability
Electronics & EEE
- UL94 V-0 / V-1: Flammability rating
- RoHS 2011/65/EU: Six hazardous substances restriction
- REACH SVHC: EU chemical registration compliance
- IEC 60707: Glow wire test (for enclosures)
- ESD-safe options: Conductive/dissipative compounds
Food Contact & Consumer
- FDA 21 CFR 177.2600: Food-contact silicone rubber
- LFGB (BfR): German food contact recommendation
- NSF/ANSI 51: Food equipment material safety
- EU 10/2011: Migration testing (overall + specific)
- Nitrosamine-free: EN 12868 compliant for baby products
How to Verify Our Certificates
We provide digital copies of all current certificates with every quote. You can also request verification through the issuing body directly — just ask us for the certificate number and issuing organization.