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 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?
Collaborating with numerous medical device companies to 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.
Frequently Asked Questions
What is medical device contract manufacturing?
Medical device contract manufacturing is the process where specialized companies, like PRO-TECH, produce medical devices on behalf of medical device manufacturers. This service includes everything from assembly to packaging, and sterilization management, ensuring high-quality products that meet stringent regulatory requirements.
What quality standards does PRO-TECH adhere to in its manufacturing processes?
At PRO-TECH, we are committed to maintaining the highest quality standards. We are FDA-registered and ISO 13485 certified, with a focus on consistent quality and strict quality controls. Our advanced Quality Management Systems help ensure that every product meets or exceeds industry requirements, safeguarding patients from potential risks.
What types of services do medical device contract manufacturers like PRO-TECH offer?
PRO-TECH provides a wide range of contract manufacturing services, including packaging, assembly, sterilization, and validation. We also offer custom-sewn solutions for medical devices like carrying cases, wearables, and other accessories that ensure a comfortable experience for patients. , We have been helping medical device OEMs with a broad range of packaging solutions for over 40 years!
How does PRO-TECH manage the phases of production and ensure quality throughout the manufacturing process?
PRO-TECH follows a comprehensive process, from initial consultations to final product delivery. The initial consultation phase begins with planning meetings with potential customers to understand their requirements, flesh out key details, and start to explore possible packaging and assembly solutions. After that, at each stage of the process, we have dedicated team members following the product throughout the process to ensure that every step is followed. We also offer our customers a 24/7 portal for them to track their projects at each stage so that they know where they are in the process at any point in time.
What advantages do medical device companies gain by partnering with PRO-TECH?
Partnering with PRO-TECH offers medical device manufacturers access to over 40 years of experience, advanced technology, and specialized manufacturing services. Our focus on quality, compliance, and innovative solutions allows us to meet the unique needs of each client.
What are PRO-TECH’s capabilities in medical device packaging and sterilization?
PRO-TECH provides contract packaging and sterilization services as part of our end-to-end solutions. Our sterilization management includes both on-site steam sterilization and managed third-party EtO and Gamma sterilization. We handle the packaging design, assembly, and validation, ensuring that your products are delivered to the market with the utmost care and in compliance with all regulatory requirements.
How does PRO-TECH ensure the safety and reliability of its medical products?
We prioritize safety and reliability by adhering to the strictest manufacturing practices and regulatory requirements. Our fully equipped cleanroom facilities, along with process validation and quality controls, ensure that each product meets industry standards, minimizing potential risks during clinical trials and in healthcare environments.
Contact us
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Tel: 562-207-1680
Fax: 562-207-1699
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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