Pro-Tech Design & Manufacturing, Inc.
Pro-Tech Design & Manufacturing is a family-owned, FDA and ISO 13485 registered company with over 40 years of expertise in medical device contract manufacturing, specializing in packaging, assembly, sterilization, laboratory services, and innovative solutions. Committed to high-quality standards, regulatory compliance, and continuous improvement, they serve a broad range of clients from startups to Fortune 500 companies, emphasizing safety, usability, and technological advancement in their offerings.
Industries
Nr. of Employees
medium (51-250)
Pro-Tech Design & Manufacturing, Inc.
14561 Marquardt Ave., Santa Fe Springs, CA 90670
Services
End-to-end sterile and non-sterile packaging services including design, pouching, tray formation, sealing, labeling and packaging validation performed in controlled environments.
Manual and automated assembly services performed in controlled cleanroom environments with kitting, testing and integration to packaging operations.
In-house ISO 17025 laboratory services including seal integrity, accelerated aging calculations and testing, bioburden and LAL testing, and other packaging qualification tests.
Sterilization processing support and sterile-package design compatibility services covering autoclave, EtO and radiation sterilization considerations, process monitoring and sterilization-related guidance.
Certified EtO sterilization services and facility capacity to support EtO-compatible medical devices, provided near manufacturing sites to reduce logistics and increase throughput.
Custom sewn solutions including product design, prototyping and production using manual and automated sewing for wearable and protective device components.
End-to-end sterile and non-sterile packaging services including design, pouching, tray formation, sealing, labeling and packaging validation performed in controlled environments.
Manual and automated assembly services performed in controlled cleanroom environments with kitting, testing and integration to packaging operations.
In-house ISO 17025 laboratory services including seal integrity, accelerated aging calculations and testing, bioburden and LAL testing, and other packaging qualification tests.
Sterilization processing support and sterile-package design compatibility services covering autoclave, EtO and radiation sterilization considerations, process monitoring and sterilization-related guidance.
Certified EtO sterilization services and facility capacity to support EtO-compatible medical devices, provided near manufacturing sites to reduce logistics and increase throughput.
Custom sewn solutions including product design, prototyping and production using manual and automated sewing for wearable and protective device components.
Expertise Areas
- Medical device contract packaging
- Medical device contract assembly
- Sterilization methods and sterilization-support services
- Packaging validation and ISO 17025 laboratory testing
Key Technologies
- Cleanroom technology (ISO Class 7–8 / Class 10,000)
- Ethylene oxide (EtO) sterilization
- Steam sterilization (autoclave)
- Gamma irradiation and electron beam (E-beam) sterilization
News & Updates
PRO-TECH Design & Manufacturing was nominated for the Orange County Business Journal’s Family-Owned Business Award for the third year in a row.
Participation in the event scheduled for May 13-14, 2025, at the University of South Florida's CAMLS.
Celebrating 45 years of excellence in medical device contract manufacturing, led by founder and CEO Pam McMaster.
Participation in the event from February 4-6, 2025, at the Anaheim Convention Center.
Reflections from PRO-TECH President Aaron Swanson on 2020 and outlook for 2021.
Discussion on the importance of packaging in maintaining device sterility and protection.
PRO-TECH Design & Manufacturing was nominated for the Orange County Business Journal’s Family-Owned Business Award for the third year in a row.
Participation in the event scheduled for May 13-14, 2025, at the University of South Florida's CAMLS.
Celebrating 45 years of excellence in medical device contract manufacturing, led by founder and CEO Pam McMaster.
Participation in the event from February 4-6, 2025, at the Anaheim Convention Center.
Reflections from PRO-TECH President Aaron Swanson on 2020 and outlook for 2021.
Discussion on the importance of packaging in maintaining device sterility and protection.