Business Details
Medical Device Manufacturing Experts in Lake Geneva, WI
At Plas-Tech Engineering, we specialize in delivering high-quality medical products and injectables tailored to meet diverse customer needs. With over three decades of experience in medical device manufacturing, our expertise ensures precision and efficiency in handling projects of any size and complexity. Our FDA-registered, ISO 13485-certified facilities reflect our commitment to quality and compliance. We prioritize confidentiality, integrity, and transparent relationships with customers, employees, and suppliers. Our cross-functional teams mirror client practices, ensuring alignment with industry standards.We maintain ISO Class VI-VIII clean rooms and general white room molding capabilities to uphold rigorous quality benchmarks. Controlled expansion of in-house capabilities, including value-add design and engineering, supports our mission to be a trusted partner in medical manufacturing. Our dedication to innovation and disruptive solutions drives us to bring client concepts to life while fostering a culture of continuous improvement.
Services
Pre-Sales Engineering
Prototyping
Tooling
Molding
Sterilization
Medical Device Manufacturing
Highlights and features
- We offer 30+ years of expertise in medical device manufacturing.
- Our facilities are FDA-registered and ISO 13485 certified.
- We maintain ISO Class VI-VIII clean room capabilities.
- Our cross-functional teams mirror client quality practices.
- We prioritize confidentiality, integrity, and transparent partnerships.
Associations and certifications
- ISO 13485
- FDA
Services
Pre-Sales Engineering
Our pre-sales engineering team collaborates closely with clients to refine concepts and ensure manufacturability. We provide expert guidance on material selection, cost optimization, and regulatory compliance. Our engineers leverage advanced tools to deliver tailored solutions that align with client objectives and industry standards.
Prototyping
We offer rapid prototyping services to validate designs and accelerate time-to-market. Using precision tools, we create functional prototypes for testing and iteration. This process ensures final products meet performance, safety, and quality requirements before full-scale production.
Tooling
Our tooling services include custom mold design and fabrication for complex medical components. We utilize CNC machining and EDM technologies to produce durable, high-precision molds. This ensures consistency and efficiency in large-volume production runs while maintaining strict tolerances.
Molding
We specialize in precision injection molding for medical-grade plastics. Our ISO-certified clean rooms support Class VI-VIII requirements, ensuring contamination-free production. Automated systems and real-time monitoring guarantee repeatability and compliance with stringent quality standards for critical healthcare applications.
Sterilization
Our sterilization processes meet global regulatory demands for medical devices. We employ validated methods such as ethylene oxide and gamma radiation to eliminate microbial contamination. Each batch undergoes rigorous testing to ensure sterility, safety, and compliance with ISO 11135 and ISO 11137 standards.
Questions
What medical manufacturing services do you offer?
We provide pre-sales engineering, prototyping, tooling, injection molding, and sterilization for medical devices and injectables.
Are your facilities certified for medical production?
Yes, we are FDA-registered and ISO 13485 certified with ISO Class VI-VIII clean room capabilities.
How long have you specialized in medical manufacturing?
We have over 30 years of experience delivering precision-engineered medical device solutions.
Where are your manufacturing facilities located?
Our facilities are in Lake Geneva, Wisconsin, centrally located between Chicago and Milwaukee airports.
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