Tustin (USA)
Trelleborg Sealing Solutions Tustin is a full service provider and contract manufacturer for high quality manufacturing and engineering services for medical products, including components, finished medical devices and drug combination products. Project volumes ranging from prototype quantities to millions per annum.
Strengths
- Medical and drug device manufacturer
- Strategic quality program in place with a focus on GMP compliance and best practices
- Experienced and highly-qualified team with expertise in medical product and manufacturing process development, FDA and international regulatory compliance, and continuous improvement
- Strategic supplier on approved supplier list with major medical device OEM’s
- Class 7 (10.000) and Class 8 (100.000) cleanrooms
Products
- Project Management for product and process development for medical devices and combination products
- Specialized assembly, packaging, sterilization, labeling, inspection, testing, and process and/or production controls
Materials
- Customer requirements dependent – polymers, silicones, metals, bio-absorbable materials, drugs
- Over 30 years’ of experience in all types of silicone materials and fabrication
Industries Served
- Medical components and devices, drug combination components and devices
Certifications
- ISO 13485
- FDA Quality System Regulation (QSR) CFR 21 part 820 Compliant
- FDA Current Good Manufacturing Practices (cGMP) CFR 21 part 210 & 211 Compliant
- Licensed by the State of California for Device and Drug Manufacturing