CERTIFICATIONS

Q: What certifications does Innofiber hold?

A: Innofiber maintains ISO 13485:2016 and ISO 9001:2015 certifications, along with CE product markings and RoHS/REACH compliance. The company is also an FDA‑registered facility.

Q: What does ISO 13485:2016 mean for OEM customers?

A: ISO 13485:2016 certification demonstrates that Innofiber meets stringent quality and regulatory requirements for medical device manufacturing, ensuring repeatable, compliant production of photonic and fiber‑optic components.

Q: Is Innofiber compliant with RoHS and REACH standards?

A: Yes. Innofiber’s products meet RoHS and REACH compliance requirements to ensure safe material use and regulatory alignment across global markets.

Q: Is Innofiber an FDA‑registered manufacturing facility?

A: Yes. Innofiber is an FDA‑registered facility, supporting OEMs who require medical‑grade fiber‑optic components and sterile or pre‑sterilized product builds.

Q: How does Innofiber maintain consistent product quality?

A: Innofiber uses LEAN manufacturing practices, strict traceability, and validated quality systems to ensure reliable production across all fiber‑optic cables, light guides, and sub‑assemblies.

FACILITIES

Q: What manufacturing capabilities does Innofiber have in‑house?

A: Innofiber operates a fully equipped manufacturing facility with optical fiber draw towers, multi‑axis CNC machining, in‑house machining teams, rapid prototyping, and full design‑to‑production lifecycle support.

Q: Does Innofiber have a cleanroom for medical or sterile products?

A: Yes. Innofiber maintains a certified 1,200 sq. ft. Class 7 cleanroom designed for sterilized and pre‑sterilized product builds and strict medical manufacturing requirements.

Q: How large is Innofiber’s manufacturing facility?

A: The company operates an 18,000 sq. ft. facility, with 14,000 sq. ft. dedicated to manufacturing and production capacity.

Q: Does Innofiber support rapid prototyping?

A: Yes. Innofiber offers rapid prototyping using advanced machining equipment, 3D printing, and engineering software to accelerate development for OEM partners.

Q: How does Innofiber ensure production efficiency?

A: The company implements LEAN manufacturing practices to improve efficiency, reduce waste, and optimize throughput across all product lines.

MARKETS & APPLICATIONS

Q: What industries does Innofiber serve?

A: Innofiber provides custom photonic and fiber‑optic solutions for medical, analytical instruments, industrial automation, aerospace & defense, and semiconductor manufacturers.

Q: What medical applications use Innofiber’s photonic products?

A: Innofiber supplies fiber‑optic illumination cables, probes, and sub‑assemblies used in medical devices including endoscopy, surgical visualization, and diagnostic imaging systems.

Q: Does Innofiber supply fiber‑optic solutions for analytical or life‑science equipment?

A: Yes. Innofiber develops illumination fibers, light guides, and photonic sub‑assemblies for analytical instruments such as spectrometers, molecular imaging systems, colorimetry sensors, and life‑science diagnostic equipment.

Q: What solutions does Innofiber provide for industrial OEMs?

A: For industrial applications, Innofiber supplies fiber‑optic components used in photoelectric sensing, automation equipment, and custom illumination systems for high‑demand environments.

Q: Does Innofiber support aerospace and defense projects?

A: Yes. Innofiber designs specialty fiber‑optic products built to meet stringent performance and durability requirements found in aerospace, defense, and high‑reliability applications.

Q: What solutions does Innofiber offer for semiconductor equipment?

A: Innofiber develops fast, flexible, and precision‑driven photonic designs for semiconductor capital equipment, supporting OEMs with custom illumination and sensing assemblies.

Q: Does Innofiber build disposable medical light guides?

A. Yes. Innofiber has many years of experience designing and building disposable light guides used in the medical field.

Q: Does Innofiber have high temperature application capability?

A. Yes. Innofiber supports high‑temperature applications using glass‑based fiber solutions rated for operation up to 900°F, making them suitable for demanding industrial environments. Plastic fiber options are also available for lower‑temperature needs up to 158°F.