CALL US: +1 949.769 .3200 HOME MANUFACTURING PRODUCTS ABOUT US CONTACT Manufacturing Capabilities Quite simply if it can be built we can build it. From surgical implantables (screws, fixation systems), devices with electronics, custom software development, complex assemblies and sub-assemblies, sterilization, complex materials, and injection molding. Implantable fusion devices Sterilized screws and fixation systems External fixation systems for trauma Surgical tools and instruments Powered devices with smart technologies Disposable adapters (cutters, shavers, drivers) Injection molding for drug delivery High precision highly complex assemblies Custom design projects Competitive Advantages Pro-Dex is a big step ahead of the pack. From our location, to our industry experience and comprehensive suite of services we lead the contract manufacturing industry for good reason. Strategic Location 30,000 manufacturing square feet in the heart of Irvine, CA. Regulatory Compliance 510(k) filings to device history files let us manage your documentation needs. ISO 13485 Certified Our facility is registered with the FDA and CA Department of Public Health Food & Drug Branch. Industry Leader We have extensive experience precision manufacturing for the world’s largest companies. Long Manufacturing History Pro-dex was established in 1978 and has delivered over 40,000 powered devices. Manufacturing Assembly Our assembly model utilizes cells with extensive cross training and testing. Testing Solutions Standalone service. Let us design your testing protocols. Quality is our DNA. Fully Transparent Pro-dex is a public company and trades under the symbol “PDEX.” Engineering & Staffing Solutions Our Engineers will design your product for manufacture. Need additional resources? We’ve got them. How it works: Our Design & Manufacturing Solutions Prodex offers turnkey manufacturing solutions for a wide variety of industries. From prototyping to engineering to manufacturing and assembly to validating your suppliers and supply chain management to meeting regulatory and compliance needs we have solutions for every aspect of your project and manufacturing needs. Bringing products to market is our specialty. Schedule a facility visit today! We invite you to come see our six phase development process in action; we begin with proof of design and product feasibility testing, leveraging our in house engineering talent and long history of manufacturing experience. We then develop designs for manufacturability and concurrently develop processes for manufacture and assembly. Prior to product transfer and release all of our products go through a rigorous verification and validation process. Finally we conduct post production evaluations, continually optimizing and making process improvements. 1. Design. Most of our manufacturing opportunities start with the signing of a non-disclosure agreement (“NDA”) and a discussion amongst our engineering teams about the particulars of the product or part of interest. Our engineering team can review your drawings for manufacturability or create a design from scratch given your product specifications. We will leverage our manufacturing expertise and offer suggestions for amendments where we see potential for improvements. We often create working prototypes and 3D prints of product concepts to validate the designs and proof of concept. The convenience of our location allows us to work closely with your development team. We also offer engineering contractor services if more bandwidth is needed. 2. Manufacture. Our versatile high precision manufacturing facilities are able to produce on a low volume quick turnaround basis as well as on a high volume cost effective basis. From high precision injection molding and tooling to ultrasonic welding or precision motion control to machining at extremely tight tolerances we excel at speed to market, high quality, on-time deliveries and reduced manufacturing costs. Our engineering team will work to help every step of the way, working hard to avoid problems before they happen and suggesting alternatives to reduce the cost of tools, use of parts, and optimize the manufacturing so that it is lean and well within your specifications. We are one of only a few local FDA registered and ISO 13485 certified facilities with decades of experience manufacturing finished medical devices. Our employee base is extremely loyal with five of our key machine shop employees having almost a century of experience between them. 3. Assembly. Our assembly facilities are equally versatile. We assemble in stages with regular testing intervals to increase efficiency and virtually eliminate any fully assembled performance failures. Testing is built into the culture of our assembly team. Open channels of communication between our inventory, manufacturing and assembly teams with strong management oversight (meet our Director of Operations Mr. Rick Boyd) allows for a culture of continuous improvement. Assembly is an important aspect of our turnkey product/compent concept to market strategy. We aren’t simply a contract manufacturer. We are capable of driving your project from beginning to end. 4. Testing. Rigorous testing is a key aspect of our Quality Management System. We are so recognized for the quality of our testing that some customers outsource their finished product testing to our facilities for our team to test on their behalf. Our engineering is involved every step of the way, monitoring testing outcomes and constantly looking for product design enhancements. Our product testing capabilities serve as a standalone capability for Pro-dex and are another way that we set ourselves apart from the pack, offering solutions at every stop of the manufacturing process. 5. Documentation & Compliance. These are critical aspects of the manufacturing in many industries. In the manufacture of medical devices manufacturers are required to file 510(k) Clearances notifying the intent to market a medical device. Quality System Regulations, Design History Files, and strong and effective documentation controls are essential to proper development and manufacturing. With Pro-dex you can outsource your documentation and compliance needs or leverage the expertise of our in house team. We have been qualified by some of the largest medical device distributors in the world and are more than capable of handling your documentation and filing requirements (meet our Director of QA and Regulatory Affairs Angel Domingo) 6. Delivery. Pro-dex offers multi-directional logistics and fulfillment. We not only drop ship finished and laser etched products globally but we receive finished devices for repairs and refurbishments. Our job is to not only manage every aspect of the product design, manufacture, assembly, and testing, but to also provide the backup and repair services needed for you and your customers to use our products with the peace of mind that we can service them. Our ERP system keeps us on top of inventory and delivery times and ensures that we deliver your products exactly when you need them. Pro-dex in house manufacturing capabilities Pro-Dex is a big step ahead of the pack. From our location, to our industry experience and comprehensive suite of services we lead the contract manufacturing industry for good reason. Prototyping & Validation We have seen a lot of product ideas and can help you successfully develop your concept for manufacture. Design & Technical Drafting Experience drawing detailed design specifications with hardware/software interfaces, tolerance analyses & manufacturing feasibility. Electronics & Software Experts in embedded systems and solutions (battery powered, torque limiting software, led displays, etc). Mechanical Engineering & Design Specialize in transforming ideas and concepts into functional prototypes ready for manufacturing. Precision Machining & Assembly Decades of experience with tight tolerances and flexible & high mix manufacturing. Quality & Compliance At our regularly audited ISO 13485 certified facilities good manufacturing practices are embedded in our culture. Testing & Other Capabilities Circuit and PCB design, programming (C++, Java, Visual Basic, etc), display sub-systems for instrumentation. 1. Design & Technical Drafting.We specialize in transforming ideas and concepts into functional prototypes ready for manufacturing. Our engineering professionals have the innovative skills to give your project its competitive edge. 2. Electronics & Software. Our team is knowledgeable in embedded systems and solutions; enabling your products to have the intelligence they need. Our portfolio of product development includes low power, battery operated hand-held devices; precision motion control and positioning devices; control functions with unique patient safety technology. A. Embedded Systems: * Motion control, including console and battery operated systems * Physiologic signal processing, display and analysis * Rotary drive systems including handheld “smart” power screwdrivers * Data acquisition for low signal/high noise environments It is our job to be analytical and methodological to ensure the toughest of problems are solved correctly. Our engineers specialize in writing, designing, and developing effective and efficient algorithms. B. Engineering Solutions: 3. Mechanical Engineering & Design. We specialize in transforming ideas and concepts into functional prototypes ready for manufacturing. Our engineering professionals have the innovative skills to give your project its competitive edge. 4. Precision Machining & Assembly. Your experience at Pro-Dex as a customer is important to us which is why we are dedicated in meeting your expectations while fulfilling regulatory requirements. With our experienced work force and in-house specialized equipment we are in the business to support a variety of industries and product lines. 5. Quality & Compliance. We have over 15 years experience providing quality and compliance assurance in conformance to FDA and ISO 13485, Medical Device Directive and other standards. At Pro-Dex, our reputation is on the line, as is yours; it is therefore our goal to ensure your product is safe and effective. Good manufacturing practices are apart of our culture. Our facilities are regularly audited to ensure continued adequacy and compliance. We can offer a range of solutions tailored to your specific needs. 6. Testing & Other Capabilities. 7. Prototyping & Validation. At Pro-dex we are experts at taking your back of the napkin ideas and creating product prototypes. With our in house 3D printing capabilities and superb engineering team we have everything needed for quick turnarounds. Our Engineers have expertise in metallurgy, mechanical engineering, aerospace, industrial and manufacturing. Prototyping is a huge part of what we do and the starting block for every aspect of our engineering and design process. Our state of the art product development equipment allows us to quickly manufacture a working prototype for validation and conceptualization of your product ideas. Still not sure how our business works or what our manufacturing capabilities are? Don’t hesitate to contact us! We pride ourselves at being extremely responsive and chances are that our engineering team has already built what you need. Motion & Object Detection Feature Extraction/ Signal Trending Imaging & Image Enhancement Optical Character Recognition Decoding of 2D Barcodes Temperature Control Conceptual models through to designs ready for manufacture Variety of materials- plastics and composites, steel, aluminum, alloys Machined, cast and molding processes High reliability- harsh environment, autoclave, dishwasher Surface treatments, finishing, coatings, anodize Thermal, mechanical- vibration, shock, load and stress analysis Powered or manual devices for orthopedics, CMF, dental, ENT Enclosures, housings, components, sub-assemblies Disposable and reusable devices Precision Machining Flexible & High Mix Manufacturing Components to Finished Products Assembly Capabilities Historical On-time Delivery of 98% Rapid Prototyping Lot Tracking Speed to Market Material Certification EProcess Validations Lean Manufacturing Risk Management- Services, Templates, Forms Quality System Services – Procedures, Work Instructions, Forms, Technical Writing, System and Process Audits Validations – Creation of Protocol, Execution, Report Writing Inspection Services – Capabilities include CMM, Optical, Electronic and Mechanical Control Plans – Master, Process and Inspection Process Mapping Circuit and PCB design for virtually any application and form factor Electronics design from low level, low frequency analog through RF and high clock rate DSP applications PCB layout and design Full prototyping and board/bench debug Detailed design specifications including hardware/software interfaces, tolerance analyses Programming languages including C/C ++/Java/Visual Basic/Forth/LISP/UML Operating systems including Kadak / VxWorks / ThreadX / SEGGER emboss / PowerPack / Micrium II, III/Free RTOS Drivers and support for SPI, IIC, UART, ADC, GPIO, RTC Superb documentation of software from top level graphical architecture through extensive source code commenting Display sub-systems for instrumentation, monitors Privacy Notice|ProPhoto Photography Blogsite