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Custom Medical, Pharmaceutical, Laboratory (lab automation) and Semiconductor Assembly Machines and Manufacturing Process Equipment Developers:  Medical Device Mfg. Equipment, Medical Device Packaging, Pharmaceutical Cleanroom Process Automation, Medical / Research Laboratory and Semiconductor Manufacturing Systems Development according to FDA, GMP, Semi and Pharmaceutical Standards (See Products page below).

Products

Processes, Operations and Systems Involve:  Medical device manufacturing equipment, medical disposables and medical device packaging, general process automation and automated assembly according to FDA (Food & Drug Administration), GMP (Good Manufacturing Processes) standards / ultrasonic welding / automation for medical, pharma, research laboratory use (lab automation) and manufacturing environments, hospitals, pharmacies and health care (healthcare) facilities.  Systems involve life sciences, physicians and hospital or lab personnel, medical disposable products, medical syringes assembly and packaging, medical devices, needles, medical safety syringes, medical catheters, medical pumps (fluids, blood and blood plasma, reagents, sterile water, etc), 316 stainless steel frames and vibratory feeder bowls, Class 1, 10, 100, 1000 10,000, 100,000 cleanroom (clean room, cleanrooms) robots and equipment, ultrasonic welding, medical device assembly machinery, cleanroom robots, 510 k / 510k validation / assembling of catheters, syringes, small plastic parts, ultrasonic welding and bonding, labeling / systems including needles, pumps, micro tubing and surgical instruments packaging.

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Ultrasonic Welders: 

Ultrasonic Welders ( Welding)  include BRANSON, Branson US, Branson ultrasonic welders / welding / weld, branson corp, Herrmann ultrasonic welders, herrmann ultrasonics inc, herrmann, HERRMANN, Herrmann Inc, dukane inc, dukane, DUKANE ultrasonic welders, DUKANE, Sonitek, Sonitek inc, soniteck, Sonitek, Sonitech, Sonitek sonic Sonotronic nagel, sonitek, heat staking, enertech, ercon associates, ercon, ercon associates, sonobond, Sonobond, sono-bond, ultrasonic assembly, evergreen, ever green ultrasonic company welders, plastic assembly systems, rinco, roop, sanden, shantou, sonic force, rinco, sonics & materials, telsonic ultrasonics, teslsonic, acoustical tooling company, ultra sonic seal, ultrasonics for less, ultrasonics for less, weldtech,  ultrasonic cleaners, cleaning, lacrois, maschinenfabrik, Abbeon cal welders, alternative robotics robotic ultrasonic welders, American technology, slitters, formers heatstaking, heat-staking, lacroix, ultrasonics, lacroix industries, branson ultrasonics corporations, dukane, cae ultrasonics, ceia ultrasonic, Inc, & thermal technologies ultrasonic welders, welders sealers, splicers, seamers, applied ultrasonics, benchtop-ultrasonics, Stapla ultrasonics, ceia, , ewi, edison welding institute, ha, imeco, branson ultrasonic welding, branson ultrasonic, branson ultrasound, branson, Sonobond Ultrasonics, herrmann ultrasonics, herrman, hermann, herrman, Dukane, 

 Medical Suppliers, Processes & Components:  

FDA, GMP, Validation, Medical device assembly machinery, Urethanes, cyanoacrylates, curing equipment, dispensing systems, henkel, bonding solutions, thermal-transfer printer, flexible circuit, gas-flo calibrator, northfield, superiortube, surmodics, knf, vibration welder, thermoplastics, international polymer engineering, jamak healthcare technologies, packworld, scapa medical, intraocular lenses, UV Cure, medical applications, lesco, curemax, uv u v u-v u. v. exposure lamp, panel components, corporation, interpower, iso 9001 certified, PMD, performance motion devices, Watson marlow pumps bridal, silicone tubing, bio-pharm certification, usp class vi, iso, validated processes, no contamination, lab transfer, pump , c brewer co, scientific molding manifesto, liquid silicone rubber, b. braun, gamma, gamma, eto, eto, e-beam, e-beam sterilization, sterilization, sterilize, sterilize, lemo, redel, memgen, FDA  GMP medical cleanroom automation machines, FDA, GMP, medical devices, pharmaceuticals, laboratory, semiconductors, medical disposables, medical devices, medical packaging, u.s. tool, htr, hi-tech rubber, nusil, nusil technology, precision fluoroplastic tubing, ptfe, pfa, feb, etfe, peek, pei, catheter, ulbrich precision, nook, lytron, odu В– usa, miniaturization, miniature, semiconductor industry, tube, tubing, loctite light cure acrylic, cyanoacrylate, epoxy, polyurethane, flashcure adhesives, polyethylene, westpack, exhibitors, tfx, uti, Watson-marlow, wytech, heat-shrink tubing, shaped tubing, donatelle, mx, mossier zahner ag, mitutoyo, mitutoyo, mitutoyo America, catheter tip-forming systems, ercon, catheter hold driller, technical innovations, small diameter tubing, laparascopic instruments, drills, trocars, trocar needles, detal instruments, orthodontic turnbuckles, iv extension sets, burron oem, polymer tubes, micromo, pexbond, ndh medical, efd high pressure dispensing tool, reservoir, impulse sealing, pittman, motion controllers, positioning systems, velmex, tinius olsen testing machines, Edmund industrial optics, Millipore test-strip guide, southpack, south pack, pharmaceutical, nutraceutical packaging, cosmetic, personal care packaging, material handling, Georgia, show, Kawasaki, comcoinc, comco inc deburring, needles, atlantic design and manufacturing show, pacific design and manufacturing show, gore, uti, b braun safety sample kit, university, bosch rexroth, ball rail, roller rail systems, robotics, cleanroom-compatible workstations with ESD protection, modular cleanrooms, ts conveyors, varioflow flexible chain conveyor, permabond adhesive, dymax optically clear epoxy, materials, devcon, dymax, loctite, permabond, avail, battelle, Dupont medical packaging, medical device & diagnostics industry, operators safety, carpel tunnel syndrome, ergonomics, ergo, repeatitive, repetitive motion injury, cp, viscosity, fluortek, memry, beahm ophthalmic surgery instruments, cardiac pacemaker leads, microtube, handy harmon tube company, designs, pad printing, hot stamping, band printing coating, precision machining, hold drilling and hold punching, engraving, band printing, heat forming, cuffing, multi-lumen forming, profiles, bullet tips, flairs, conical tips, welding, ultrasonics, ultra-violet, solvent, solvent bonding, solvent bonding, adhesive, centerless grinding, polypropylene, acetal, acrylics, anaerobics, epoxies, light curing, silicones, services, injection-molded parts, advanced technology, porex medical products, uti corp, jsw, iso 9002, dip molding, apex medical, Patrick plastics corp, coorstek molded components, coarc, entegris, contract manufacturing, the tech group, gas-assist injection molding, entech plastics, tech-etch, photoetched luer connector, virgin nylon, resin, new England catheter corporation, peter paul solenoid valves, zeus bump tubbing, dymax, solvent-free, microscopy, spin coating, meder, instron, zeus pebax tubing, medical tubing, wound care, wytech, tyco electronics, syring adapter, viscosity, dispensing system, micro brushes, medical instruments, mill-rose, foam, asg, scs, Hamilton, oem, precision fluid handling, pipette, vistalab, composite, antistatic, connectors, film, avery dennison, release agents, dry film lubricants, air filters, solvent dispenser, unislide, precision positioning equipment, electron energy corporation, novotechnik, multivac, vacuum-chamber, saint-gobain performance plastics, tygon, surgical, medically pure, pharmaceutical, biosil, bio sil, laser, renishaw, anchor lamina, precision medical extrusions, heart, dunn, test inspection sensors, coast scientific, Kaman, duradyne, ault, Ethernet, interlink, pressure transducer, medical components, jeropa, abbott laboratories, abott, abbot, abbott labs, ultrasonic soldering, misonix, kaeser, spt, small precision tools, ceramic injection molding, moulding, radiopaque compounds, Puerto rico, Puerto rico, pridco, pacemakers, defibrillators, Medtronic, Baxter, st. jude medical, Guidant, lacey, PPT machine vision, pvc tubing, saint-gobain performance plastics, reusable metal needles, fishman, fluid management systems, rheodyne, maxon precision motors, microlumen, premold reaction injection molded parts, Teflon tubing, TFE, FEP, PFA, , ID, OD, MEMS, Liquid flow sensors, Molding, Medical-Grade adhesives, micromachining, micro-machining, electrical-discharge machining, EDM, precision machining of medical devices, micro EDM systems, Sarix SA, millimeters, microns, burr-free, surgical needles, implantables, medical parts, tungsten, titanium, elgiloy, molybdenum, nitinol, polyimide, servo-flow meter-mix-dispense system, sealant equipment & engineering inc, koa speer, minco, servometer, lee, pumps, miniature, lpv, peristaltic pumps, variable volume pumps, small, 2, 5, 10, 20, 50, 200, 250, 500, 1000, ul, nanoliters, nano-liters, microliters, micro-liters, liters, keystone, mikron bostomatic, machining centers, tooling, part production, adam spence, feintool fineblanking, electric servo presses, schmidt, lathes, mills, laser tube-cutting, altamar laser & control, pall medical, filtration, separation, solution, vacuum protection filter, prosthetic, maxon precision, piezoelectric motor, national institute of standards and technology, qrs diagnostic, amorphous metal, liquidmetal technologies, surgical specialties, depuy orthopedic, zirconium, alloy, hygienic, hytone, hysynal, apex medical, synthetic elastomer, g&l precision die cutting, thermo life energy, cornell pittman, mdmeast, mdm west, medical design & manufacturing show exposition, west, west anaheim, california, mdm west, md and m, m d and m, medical devices and manufacturing west trade show, 2004, 2005, 2006, west pack, insert molding, luer fittings, grips, ports, wires, clean room , kanban, kit packaging, full lot tracking, traceability, bar coding, tipping, aga chemicals, medical adhesive tapes, the medtech group, load cell, globtek, extrumed, handy harman, rovema, bagging, ellsworth, upchurch scientific, ink-jet printing diagraph, master bond medical adhesives, non-toxic, specialty silicone, tube cutter, asg medical, metal tubing, newage.

 

Medical Device Industry Related Systems, Equipment, Suppliers & Processes:  Certified Class 10, 100, 1,000, 10,000, 100,000, ten, one hundred, one thousand, ten thousand, one hundred thousand Cleanroom (Clean Room, CleanRoom, cleanrooms) equipment, robots (robot, robotics, robotic) compatible machinery.  Quality System Regulations (QSR) FDA GMP QSR  ISO 9000 certification, EN 46001, FDA implementation ASQC certification device industry ISO , 9000, 9001accuracy and reliability  statistical test methods, GMP MMD manufacturing processes for medical, root cause determination, corrective action design of experiments   hospital, physician, contract manufacturers contract test laboratories device remanufacturers custom  areas medical sector production lines custom Medical Assembly & Packaging Machinery High Speed Medical Assembly Machines forming lines converting machinery, production automation, purpose machinery, , machinery design, robotics systems, web guiding traceability  knowledge and adherence to FDA, GMP and ISO 9000 requirements quick turn design and manufacturing medical Device Workshops Premarket (pre-market) Approval and installing processing, buildings, equipment, purchase and handling of components, production and process Part Insertion & equipment assembly machines, factory automation slitting manufacturer's quality system  GMP inspections internal test laboratories factories  foreign manufacturers quality system for the design, manufacture, packaging, labeling, storage, installation Compliance requirements device manufacturing operations  inspection and testing, calibration of measurement equipment, control issued by the U.S. FDA.  Office Comparison to the Quality devices, Quality Assurance, Receiving Inspection, Documentation, Drafting, and GMP compliance catheters   requirements, software, ISO 9001. 9000, 2000 and FDA Quality System Good Manufacturing application programs for tracking of product auditing quality system   documents, Quality Assurance, Inspection biologics, or cosmetics are for human tissues for transplantation specifications and donor acceptance criteria for human tissue for transplantation manufactured, processed, packed records, and correcting deficiencies in the quality system FDA inspection Flexibility of the GMP equipment device master record change the device master records procuring components and materials device Regulatory  U.S. FDA QSR Good Manufacturing Practices  Medical Device Reporting DSMA U.S. F.D.A. ISO 9000 Regulatory implementing U.S. FDA GMP (Good Manufacturing Practices) - to determine compliance GMP requirements safe and effective methods and procedures  surgical hand tools  design reviews, design hemodialysis FD&C Act render devices unsafe or strip production Card cutting Continous motion Indexing Scada FDA GMP dressing manufacturing clean room Quality System processes  Implementing the ISO Standard  computer software and equipment manufacturing corporation FDA Med, and lines Multi-lane strip lines Linear Validation GAMP 4 Clean Room Environment Rotary High Speed  GAMP4 FDA guidelines  batch traceability,packaging, sterilization, validation, testing, blood tubing  diagnostic xВ­ray   intraocular lens (IOL)   component raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled Sorting lines Laminating machinery, . SCADA, smooth finishes for easy cleaning, elimination of static, island placement special purpose machine for medical products industry applications. Special pharmaceutical packaging steel  avoid contamination Diagnostic effective   monitors label  repackers or relabelers  drug store labeling controls re problem data and inspects the operations procedures  article   container, wrapper complaints, corrective action, and surgical guidance documentation control meet these specifications devices be correctly processing and manufacturing medical disposable products contract assembly, and kiting.Device assembly machines, medical machines, control requirements  , processing and receiving inspection surveys Validated aseptic processing procedures strategy and prepared premarket notifications for software controlled, electromechanical, instrumentation, infusion pumps, and lymphangiographic injector propagation, materials, Medical Device Reporting (MDR) FDA Recalls & Safety Alerts The National Health Related Items Code Form , SOPs  record keeping, FDA  FD-483 computers Universal Product Code (UPC)of medical Device Regulations Medical Device class I В– Establishment registration, device listing, GMP regulation (21CFR820), labeling regulations (21CFR801/809), inadequate in-process and end-product testing, cleaning, sanitation, equipment, facilities, specifications, identification and numbering of marketed device packages  National Drug Device Directive ISO 9000 Standard. Implementing components, updating of labeling finished devices healthВ­ producing devices FDA fees for review Premarket Notification 510(k)s  Premarket Approvals Good Manufacturing Implementation FDA Medical Corporate Quality Policy. Involves  standard System Devices  CSA process control and documentation process documentation, recording standard operating procedures, documentation control  ISO 9000 Standard FDA QSR Manufacturing applied Manufacturing documenting Contract Manufacturers Contract Testing Labs Repackagers, relabelers, and Specification Developers imported devices second party package and/or label previously assure  medical devices are safe and QS Practice (GMP) requirements  Quality System (QS) regulation promulgated under section 520 of the Food, Drug and Cosmetic (FD&C) Act domestic or manufactured automation prototype Take-Out System, handling of delicate components for device assembly, validation Stainless short run engineering device assemblies Full-service capabilities production and distribution of the proposed device designing products and processes training employees purchasing regulation Repackagers, Relabelers, and Specification Developers  Establishment Registration and Device Listing for human use   Classification Regulations 21 CFR 862 to 892 and any other manufactured under a quality devices intended for human use and commercial distribution CDRH guidance documents observations  investigator manufacturing deficiencies FD-483 reports  validation, monitoring compounding raw (NHRIC) FD-483  FDA Enforcement Actions Recalls  manufacture, preparation FD-483, assembly, or processing System 1996 Quality System 1978 Good Manufacturing Practice Reg  ANSI/ISO/ASQC Q9001 ISO/DI 13485:1996ultrasonic welding and cleaning, UV and solvent bonding, pouch, bag, tray sealing, repackaging U.S. FDA GMP, , EU EMD Low Voltage Directive  and enforcing corporate ISO 9000 installed, checked and serviced; quality data be analyzed to identify and correct quality problems Device GMP Workshop U.S. F.D.A. CDRH Practices (GMP) / Quality System (QS) Regulation Medical Contract laboratories  designs or test components or finished devices  laboratories medical device manufacturers contract laboratories GMP inspections  QS Regulation  injection molding and automated assembly equipment  assembly, receiving, and off-shore operations implemented a company-wide non-conforming material procedure that provided the ability to track scrap and rework costs laboratory regulation QS, compounding, assembly, or processing chemical, physical, biological,  GMP Exemptions GMP Guidance Documents - Good Manufacturing practice (GMP) Quality System Regulation Information ISO 9001, and servicing of finished medical labeling devices evaluating finished fabrication facilities   clean secure assembly manufacturing process approved  Quality Assurance Responsible for Quality Assurance, documenting Medical Devices, addressing FDA and other regulatory issues, and records retention.  implementation controls, packaging and labeling control, device evaluation, distribution, installation, complaint handling, servicing, and records  FDA Commissioner The Good Manufacturing Practice (GMP) / Quality System Regulation brachy therapy, Premarket Notification (510K), etc. processes, conditions, renovates, repackages, restores,  device's performance or safety specifications or intended use.  Remanufacturers  device master records, validation, calibrated equipment, process controls,  methods,   periodic audits  tubing or major diagnostic xВ­ray components The Magazine for the medical,  hospital, physician,  health В­related  Distributors of Imported Devices  quality Assurance, Regulatory Affairs Support, Medical Device Industry coded, validated, and implemented calibration, In addition, must fulfill all requirements of Class I devices. Class III В– Must fulfill all requirements of Class II equipment maintenance, Regulation Code of Federal Regulations quality management and organization, device design Manufacturers  21 CFR 820.5   QS regulation ineffective investigational device exemption (IDE)   sterile package design for medical, dental device  product manufacturing segregated regulation  Manufacturers of Devices "Manufacture, preparation, propagating Devised disposable, and sterilization joint venture  Dow Corning Catheter GMP requirement applicable to the activities  labeling requirements  21 CFR 801.1 Custom Device Manufacturers Section 520(b) of the FD&C Act and the IDE regulation (21 CFR 812.3 statutory requirements approval requirements  premarket notification flexibility Medical Product Manufacturing News allowed. Contract design, labeling, QSR, EU Medical Device data servicing devices, or labeling  domestic Flexibility of the GMP Applicability of the GMP and records of device developers and manufacturers Manufacturers  documented in a written contract contractor and Class II В– Special labeling FDA Inspections FDA may conduct administrative inspections FDA may inspect facilities where food, drugs, , and Regulatory Requirements medical Standard Operating Procedures and implementing Good Manufacturing Practices (GMP) for Canadian Medical Devices Regulation Quality Assurance;  complaints Device Quality Systems Manual A Small Entity Compliance Guide information on GMP requirements quality system  control the design, Class I devices Directive  ISO 9000 Series Canon Communications, Cannon Officer filing 510k (510 k form)  medical devices evaluated and Affairs, Quality industry quality  GMP, EU Medical products design and development, prosthetics devices or accessories   bulk surgical tubing, syringes, media,  repacks  individual packages devices commercial distribution United States regulation  specifications and controls devices files, papers, processes, controls, and facilities devices resulting in over forty-nine 510(k) approvals high-speed rotary  device performance standards, postmarket (post market) surveillance, etc. devices plus Product Repair U. S. Medical system  finished devices Manufacturers of Accessories Initial Distributors Remanufacturers remanufacturer manufacturer Contract Testing Laboratories be processed  QS devices packaging devices distributing devices processing complaints and analyzing service and repair from design controls design finished Code (NDC)  Click here for our home page.

A California-based custom machine builder and systems integrator for custom factory automation and special machinery for use in a production, manufacturing environment. Our automated assembly equipment includes: Pick & place robotics / assembly & test of consumer, medical & electronic devices / dispense & cure of liquids, adhesives, lubricants, sealants, coatings & reagents / system integration / Inspection with machine vision, robot arm test handlers & automated test / factory, manufacturing, production processes. Our semi & fully automated, high-speed turnkey systems & high volume production machines achieve optimal throughput and reliability.

 

Medical Devices, Dental, Biotechnology, Electronics, Automotive Food & Beverage Industries: Industries of focus include life sciences, medical devices, medical disposables, pharmaceuticals, dental, orthodontics, biotechnology & biodiagnostics / appliances & consumer goods / automotive & heavy industry / golf / electronics, semiconductor, photonics, fiber optics & telecommunications / automated test handlers / food & beverage / candy / bakery / plastics / hardware / sporting goods / aerospace & military, fuel cell (fuelcell), safety syringes.

 

Robots, Conveyors, Indexing, Feeders, Dispensers, Labelers, Vision & Subsystems: As a systems integrator, our equipment may include subsystems such as carousels, indexing tables, rotary dial machines, pallet type conveyors, indexing or flat belt or flexible conveyors & transfer equipment / inline or rotary, asynchronous or continuous motion systems / dedicated custom tooling, intermittent or continuous motion mechanisms / cam driven, stepper motor or servo motor drives / liquid dispensing valves & robots / palletizing robots / pneumatic or hydraulic systems / web handling / label printers and label printer applicators / inkjet marking & pad printing / converting / machine vision, vision inspection & lighting / walking beams, centrifugal and vibratory bowl feeders, flex feeders, vibratory inline tracks, belted in-lines & storage hoppers / metering mechanisms / test and measurement equipment / electronic testers and test handlers / pick & place / sound, environmental and thermal enclosures & chambers / 4-axis scara robots, 6-axis articulated arms, x-y-z gantries, micro-positioning or nano-positioning stages & other multi-axis robotic solutions / ergonomic & flexible robotic work cells. 

 

Labeling, Testing, Assembly, Packaging, Fixtures, UV Cure, Dispensing & Capabilities: Our capabilities include accumulation, collation & stacking / automated assembly / custom machine build / packaging, labeling & inkjet marking or printing / parts handling / automated test / Single-source capability / value-added engineering services / manufacturing solutions / process verification, process validation, specification writing, automation simulation / equipment design & build, design to specification / retrofit of existing automation / build to print / large scale factory automation / custom fixtures / precision mechanism design / contract manufacturing / machine shop / RF, UV, ultrasonic, laser and adhesive bonding / heat staking, bundling, die cutting / dispensing & filling / clean-room & clean environment automation / testing / high-speed automated assembly systems resulting in repeatability, rapid cycle times & high reliability / total automation solutions / standard workcells / high-speed manipulators & state-of-the-art robots / conveyance systems / special, custom machine, turnkey total automation solutions / Single-station & multi-station dispensing/ lean automation / turnkey manufacturing systems and integrating third-party equipment from multiple vendors / Custom engineering, mechanical, electrical engineering and software / leak detection & measurement / gauging / washing, soaking, cleaning & flushing / mechanical and electrical design / custom machine controls and GUI interfaces, C++ & Visual Basic, Unigraphics, Catia, IGES, AutoCad and SolidWorks programming & PLC ladder logic / electrical panels / custom hard tooling & flexible tooling.

 

Orange, Los Angeles, San Diego, Riverside & other Southern California areas: We also cover Northern California, Arizona, Oregon, Nevada, Texas & other areas in the Southwestern United States & also Mexico. We sell standard products through distributors in North America, Europe & Asia.  KY Kentucky ND North Dakota AK Alaska LA Louisiana OH Ohio AZ Arizona ME Maine OK Oklahoma AR Arkansas MD Maryland OR Oregon CA California MA Massachusetts PA Pennsylvania CO Colorado MI Michigan RI Rhode Island CT Connecticut MN Minnesota SC South Carolina DE Delaware MS Mississippi SD South Dakota DC District of Columbia MO Missouri TN Tennessee FL Florida MT Montana TX Texas GA Georgia NE Nebraska UT Utah HI Hawaii NV Nevada VT Vermont ID Idaho NH New Hampshire VA Virginia IL Illinois NJ New Jersey WA Washington IN Indiana NM New Mexico WV West Virginia IA Iowa NY New York WI Wisconsin KS Kansas NC North Carolina WY Wyoming.

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