At Fieldtex Products, we specialize in medical sewing, producing medical device carrying cases and wearable medical garments. With over 50 years of experience, our Rochester, NY-based facility has been a trusted partner for companies developing medical devices, providing high-quality, durable, and compliant components.
Our Expertise in Medical Sewing
As a leading medical sewing company, we understand the unique requirements of the healthcare industry. Our team excels in designing and manufacturing custom medical equipment bags, cases, and garments that meet FDA standards. We have worked on projects that prioritize biocompatibility, durability, and ease of cleaning. Making many rounds of prototypes to ensuring they are both safe and functional.
Prototyping and Collaboration
Bringing a new medical device to market involves rigorous testing and validation. Many clients collaborate with us during the prototyping phase to develop custom cases and garments. These prototypes undergo biocompatibility testing and other evaluations before full-scale production. Our in-house design and engineering teams work closely with clients to create prototypes that align with their specifications and regulatory requirements.
Focus on Cleaning and Durability
For wearable medical devices and garments that come into direct contact with the skin, hygiene and longevity are paramount. A new product has to be designed with materials that can withstand repeated cleaning or sterilization processes without compromising integrity. many products need to go through wash testing to determine material durability, ensuring products maintain their quality and effectivness over time.
Quality Management and Compliance
While our facility is ISO 9001:2015 certified, we understand that most medical devices require adherence to ISO 13485 standards. For clients with such requirements, we maintain all necessary documentation and processes to ensure compliance, even though our entire facility is not certified to ISO 13485. This flexible approach allows us to meet diverse client needs without imposing unnecessary regulations on products that do not require them.
Why Choose Fieldtex?
- Decades of Experience: With over five decades in the industry, we have honed our skills and processes to deliver exceptional products.
- Custom Solutions: We offer tailored designs to meet each client’s specific needs, ensuring optimal functionality and compliance.
- Quality Assurance: Our commitment to quality is unwavering, with rigorous testing and inspection protocols in place.
- Collaborative Approach: We work closely with clients from concept to production, providing support at every development stage.
Partnering with Fieldtex means choosing a reliable and experienced manufacturer dedicated to supporting the success of your medical device through superior medical sewing solutions.