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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).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.