Medical Device Contract Manufacturing is Our Business!  Ventrex is an FDA registered and ISO 13485 certified firm.  We excel at providing highly personalized and responsive medical device contract manufacturing to a variety of companies, both large and small.  Our company personnel have a wealth of experience in sterile single use device, non-sterile reusable device and in-vitro diagnostic assembly, testing, packaging, sterilization and distribution.  Our employees average 22 years in the medical device manufacturing field.  We contract manufacture class I, II and III medical devices as well as electro-mechanical instrumentation.  In addition, we operate a state-of-the art clean room plastics injection molding facility producing very tight tolerance parts.

We offer personalized services.  Our management staff is very familiar with each of our customers and with every medical device we manufacture.  We are responsive.  When it’s important to you to get something done quickly, it is important to us to meet your needs.  It will be done quickly and it will be done right!

Our focus is to provide a “single source” package of medical device contract manufacturing services.  We are fully capable of providing “front end” services such as design assistance, prototyping, process development and clinical trial builds.  For many of our customers, we source, purchase, receive, inspect and stock components.  These parts can then be assembled, tested and packaged in either certified class 10,000 clean rooms or controlled environment non- clean room areas.  Through a strategic alliance, we also offer complete printed circuit board assembly including through hole and surface mount technologies employing very sophisticated equipment.  We coordinate product sterilization through ISO certified contractors utilizing Gamma and Electron Beam irradiation as well as Ethylene Oxide gas processes.

Providing outstanding customer service is the back bone of our company.  We enjoy working in partnership through out all aspects of the product life cycle.  Assuring the product we produce meets your specifications and is shipped on time is foremost in our daily activities.  If your demand suddenly increases, we will respond.  If design changes are required, count on us to take them as seriously as you do.  Recognizing our success as a medical contract manufacturer depends on our customer’s success with the devices we manufacture for them, we welcome the opportunity to work in partnership to help optimize your design for manufacturability and to reduce the manufacturing cost to its lowest un-compromised level.

Each of our customer's are unique. We tailor our services to best fit their situation and specific needs. Our services include:

Contract Manufactured Medical Devices:

We assemble, test and package in-vitro diagnostics where one or more reagents are employed. We source components, assemble, test, package, sterilize, stock and ship single use and reusable devices used in a wide variety of medical markets including:

Our personnel are skilled in assembling products of varying complexity.  We routinely manufacture products ranging from simple tubing sets to ultra-precision devices and electro-mechanical medical instruments comprised of plastics, metals, electronics, ceramics and glass. We assemble products used in cardiac output determination, cardiac re-vascularization,  cutting and cauterizing surgical intervention, ECG and blood pressure measurements, drug infusion, lactate sensing, ultra-sensitive thermocouples, blood sampling, tympanocentesis, pulse oximetry, sleep apnea, orthopedic surgery, prostate surgery, labor contraction intensity monitoring and in-vitro diagnostic processing.

With our average employee having over 20 years experience in medical device manufacturing, we are very well rounded in assembly techniques and methodology.  Ventrex has developed a number of entirely new processes for assembly of complex and unique medical devices. 

We are experts in the joining of plastic components.  Our knowledge of solvent and UV adhesive bonding is extensive.  We successfully bond even low surface energy components such as Teflon^®, Polypropylene and polyethylene. 

Our capabilities include designing, fabricating and operating assembly and test equipment ranging from straight forward tooling and fixturing to semi-automated work cells.  We can provide comprehensive electro-mechanical assembly and testing including cabling and surface mount printed circuit board population and testing.  We can assist with part and or product design when desired.  Our machine shop can fabricate machined prototypes or we can arrange stereo lithography (SLA) versions from 2D or 3D files. These SLA models can be used as the masters for short run reaction injection molded (RIM) components.

• Plastic part design
• Plastics injection molding
• Plastics assembly including silicone components
• Catheter assembly
• Nitinol wire forming
• Thermal tip forming
• Controlled siliconizing
• Silicone transfer molding
• Ultra-precision, precision and standard assembly
• Solvent and cyanoacrylate bonding
• UV adhesive, epoxy, and polymer adhesive bonding
• P.C. board assembly
• Precision and standard soldering
• Electro-mechanical assembly
• Fiber-optic processing including lens forming and polishing, bonding, gapping, cladding, polishing, fiber pyrolizing

• Glass forming
• Flow and leak testing
• Gold wire bonding
• Hermetic seam welding
• Electro-static bonding
• Ultra-sonic welding
• Thermal welding and staking
• Micro riveting
• Micro arc welding
• Short run vacuum forming
• Ultra-sonic cleaning
• Automatic and semi-automatic software controlled testing
• Electro-mechanical testing

Properly designed packaging will get your product to your customer intact and in optimal presentation without costing a fortune.  Improperly selected packaging can be very expensive and potentially severely delay a new product release.  We can assist in all aspects of packaging selection and utilize vendors who deliver quality materials, on time and at reasonable prices.  Ventrex will arrange D.O.T. approved transit testing for your product as requested.

All of our packaging equipment is fully validatable  and incorporates total process controls.  We routinely validate and monitor package seals using constrained burst testing, dye penetration and peel strength methods.

Ventrex coordinates all aspects of sterilization including sterilization validations, quarterly dose audits, annual ETO re-qualifications and routine processing.

Ethylene Oxide (EO/ETO)

We use only ISO certified processors and provide a certificate of processing with each shipment. We can help you select materials for your products which will allow you to use a preferred method of sterilization.

Gamma

E-Beam

Facilities:

Our corporate office and production facility is located in Ventura, California. Ventura is a coastal city located 60 miles north of Los Angeles and 30 miles south of Santa Barbara. Ventura County enjoys the benefits of temperate year round weather, good air quality and a large stable work force without the congestion of the Los Angeles area.

General Facility

• 35,000 square feet.
• Three class 10,000 clean rooms with class 100,000 gowning and transfer rooms.
• Class 100,000 injection molding clean room with six close loop controlled injection molding machines ranging in size from 55 tons to 220 tons.



• Multiple controlled environment and general assembly areas.
• Pre-sterile, quarantine and sterile controlled access areas.
• Production areas equipped with a wide variety of standard and specialized assembly and test apparatus.
• Receiving Inspection with 2 Instron force testers, 2 optical comparators, environmental test chambers, tool makers microscopes, durometer tester, molded stress optical analyzer, laminar flow bench, etc.
• Metrology department with NIST traceable standards for complete in-house calibration.
• Machine shop with mills, lathes, surface grinder, heat treat oven, etc.
• Morgan prototyping manual molding machine.
• Through strategic alliance, complete surface mount and through-hole pc board fabrication and testing.

Quality System:

We are proud of our quality system. Virtually all of us at Ventrex learned our trade at large medical device manufacturers. When we built the Ventrex System, we adapted the formats we knew to fit our business. We firmly believe that Quality System Requirements and ISO standards make for a much better all-a-round organization.

Ventrex manufacturers class III medical devices and as such, our quality system has been rigorously inspected by the FDA. We have never received a form 483 observation requiring a formal response. Being ISO certified, we are audited semi-annually by BSI. Since our initial certification in 1997, we have never been cited for a major non-conformance.

Our system is designed to allow easy integration into or in conjunction with our customer’s systems. We have assisted many of our start-up client’s put together a quality system which is right for their business.

Ventrex frequently produces product for our customer's clinical trials. Depending on the size and scope of the trial, we can manufacture a single lot of less than one hundred units up to multiple lots of several thousand pieces. As we have design control as one of the elements of our quality system, we can provide significant guidance and assistance in helping you work through this element of the development process. Ventrex can assist in writing marketing specifications, product specifications, validation protocols and assembly procedures and packaging specifications. We can also prepare component drawings, design labeling, design tooling and fixtures, perform risk analysis, facilitate failure modes effect analysis, conduct first article inspections, carry out product validations, coordinate sterilization validation and structure and compile the design dossier.