Contract Medical Device Manufacturing
Transform Your Ideas into Market-Ready Medical Devices
WHAT IS CONTRACT MEDICAL DEVICE MANUFACTURING?
Contract medical device manufacturing allows companies to outsource the production of their medical devices to specialized companies equipped to handle the complex requirements of medical device production. This includes design, assembly, packaging, regulatory compliance, and warehouse and delivery services.
Here, at PRO-TECH, we offer a broad range of contract medical device manufacturing services, including packaging design, assembly, packaging, and contract sterilization. We cater to a diverse range of medical device companies and are adept at handling various products, materials, and quantities.
Beyond Manufacturing: Full-Service Solutions
PRO-TECH doesn’t just manufacture your devices; we provide a suite of services to support each stage of the medical device lifecycle. For example, we offer:
- Sterilization Management: We typically manage sterilization for our customers and we offer both on-site steam sterilization, or managed EtO and Gamma sterilization through third party partners.
- Validation Services: Our on-site ISO 17025 accredited lab ensures your products are tested to the appropriate regulatory standard and are safe for clinical use.
- Warehouse Management: We manage inventory and product delivery for our customers. Lot numbers are closely monitored and tracked to ensure traceability and we boast a 95% on-time-delivery rate.
Why Choose PRO-TECH for Your Manufacturing Needs?
We bring over 40 years of experience to the table, collaborating with numerous medical device companies to assemble, package, and ensure the highest standard of safety for your products.
- Industry Compliance: We maintain a rigorous adherence to FDA regulations and ISO 13485 standards, ensuring that every product we manufacture meets or exceeds the stringent requirements of the medical device industry.
- Advanced Manufacturing Capabilities: Our facilities are equipped with cutting-edge technology and are staffed by experts in medical device assembly and production efficiency. This combination allows us to handle complex and innovative products with high precision.
- Integrated Solutions: We offer end-to-end solutions that include package design, assembly, packaging, and sterilization services—all under one roof.
- Customized Service: Each project is unique, and we tailor our services to meet the specific needs of your medical device, ensuring optimal outcomes for functionality, reliability, and market compliance.
Our Contract Medical Device Manufacturing Process
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Phase 1 – Onboarding:
- Initial Inquiry: We assess your needs and project scope.
- Getting Serious: We dive into detailed requirements and timelines.
- Quote: A personalized quote with packaging, sterilization, and validation details.
- Engage: Begin onboarding and access your personalized project portal.
Phase 2 – Validation:
- Validation Preparation: Review device, assess sterilization, and set up protocols.
- Sample Order: Produce a limited batch for testing.
- Validation Process: Test articles are built, analyzed, and validation reports issued.
Phase 3 – Product Ready:
- Production: Begin commercial production, including labeling and audits.
- Ongoing Improvements: Continuously refine processes, optimize design, and reduce costs.
Contact us
Call Us
Tel: 562-207-1680
Fax: 562-207-1699
Email Us
info@protechdesign.com
Our Locations
CALIFORNIA
14561 Marquardt Ave.
Santa Fe Springs, CA 90670
TEXAS
4041 Express Street
Arlington, TX 76001
MINNESOTA
292 E. Lafayette Frontage Road
St. Paul, MN 55107