Global Medical Manufacturing

51,000 sq. ft.

Five CNC Swiss machines, five 5-axis CNC milling machines, 38 3- & 4-axis CNC milling machines

FDA registered, ISO 13485 certified

Capabilities:

• High-precision metal multiaxis milling
• Wire EDM
• TIG welding
• CNC turning/turn-mill
• Swiss machining
• CMM inspection
• Delicate polishing & instrument assembly
• Product & process development

76,000 sq. ft.

Class 8 clean room, white room

41 molding presses (3 tons – 1,000 tons) including 10 micromolding slide machines

ISO 13485 certified, ISO 9001

Capabilities:
• Molding: two-shot, multicomponent, over, insert, micro, spin stack
• Extrusion blow molding
• Gas-assist & RJG in-process decoupled molding

134,000 sq. ft., 2 facilities

Class 8 clean room, white room

36 electric molding presses (6 tons – 610 tons)

FDA registered, ISO 13485 certified, cGMP compliant, UL listed products

Capabilities:

• Full mold design and development center using RJG
• Injection and insert molding
• Full-service contract manufacturing
• Assembly and in-process testing
• Silicone extrusion & injection blow molding
• In-house microbiology lab
• Contract sterilization (ETO, gamma, e-beam)
• Value-added services: pad printing, sonic welding, heat staking, painting, plating
• Packaging (FSS, tray, pouch, custom, automated)

180,000 sq. ft.

Tube-manufacturing equipment, metal deformation machines, laser processing & Swiss machining equipment

AS-9100, ISO 13485 certified

Capabilities:

• Metal tube manufacturing and fabrication
• ECM/ECG tube cutting
• Swiss machining
• Laser cutting
• Cleaning and finishing

180,000 sq. ft. campus, 4 facilities

Class 7 & 8 clean rooms

26 molding presses (40 tons – 280 tons)

FDA registered, ISO 13485 certified, cGMP compliant

Capabilities:

• Injection & insert molding
• PVC Extrusion
• Full tool room with certified tool makers
• Full metrology lab
• Finished device assembly
• Sterile barrier packaging

45,000 sq. ft.

Class 7 clean room, white room.

40 molding presses (28 tons – 500 tons)

ISO 13485 certified, ISO 9001

Capabilities:

• Thermoset elastomer molding, including LSR, LIM
• Injection, compression, and transfer molding
• Custom material formulating/mixing
• Dedicated automation cells

75,000 sq. ft.

~2000 sq. ft. clean room

22 CNC turning centers and Swiss machines, 3 clean lines, 4 Atmospheric Plasma Torches, 1 Vacuum Plasma Torch

FDA registered; ISO 13485, ISO 14001, FDA 21 CFR Part 820 certified

Equity M/W index: 88/100

Capabilities:

• CNC machining (3-5 axis)
• Laser engraving
• HA and Ti coating
• Grinding & polishing
• Finishing
• Cleaning
• Sterile packaging

51,000 sq. ft.

Class 8 clean room

30 molding presses (19 tons – 300 tons)

FDA Registered, ISO 13485 certified, cGMP compliant

Capabilities:

• Injection molding
• Value-added services: automated assembly, pad printing, heat staking, sonic welding, parts annealing, UV bonding
• Materials expertise
• Design support

15,000 sq. ft.

Class 7 & 8 clean rooms

FDA registered; ISO 13485 certified

Capabilities:

• Ideation / concept generation
• Prototype development & assembly
• Product design & development
• Package design & development
• DFM / DFA
• Process design & development
• Verification & validation
• Clinical, pilot, low-volume commercial manufacturing and clean room assembly

80,000 sq. ft.

23 CNC Swiss machines; 3-, 4-, & 5-axis CNC turning centers; 3 CNC multiturret turning centers

FDA registered; ISO 13485, CMDCAS, MDD certified

Capabilities:

• Cellular environment
• CNC turning & milling
• Wire EDM
• Laser etching
• Laser & TIG welding
• Polishing
• Mass finishing
• Ultrasonic cleaning
• CMM
• Assembly
• Rapid prototyping (metal/plastic)

85,000 sq. ft.

Class 8 (GP class D) clean room

viant-aura.de

2 TIG welders, 21 precision tube-drawing benches, 8 tube-forming machines (bending, flanging, reducing, tube widening), laser marking & welding machines, 21 CNC-lathes

ISO 13485 certified

Capabilities:

• Metal tube manufacturing & fabrication
• ECM and wire EDM tube cutting
• CNC turning with robotics
• Secondary finishing operations
• Cleaning and passivation

208,000 sq. ft. campus, 2 facilities

Class 7 & 8 clean rooms

FDA registered, ISO certified 11135, ISO 11607, ISO 13485, EN 550, cGMP compliant

Capabilities:

• Finished goods assembly
• Flexible production: low/high volume
• Complete packaging design services
• 4 dedicated packaging engineers

80,000 sq. ft.

Two 5-axis CNC machines, six 3-axis CNC machines, thermoforming machine

FDA registered; ISO 13485 certified

Capabilities:

• CNC turning & milling
• Metal forming/bending
• Thermoforming
• Finishing

41,000 sq. ft.

8,000 sq. ft. ISO Class 8 clean room

4 Swiss machines, 3 wire EDM, 4 multiaxis CNC mills

FDA registered; ISO 13485 certified

Capabilities:

• Complex F/G assembly
• CNC machining
• Laser processing
• Packaging and labeling

77,000 sq. ft.

Class 8 clean room, white room

35 molding presses (39 tons – 500 tons)

FDA registered, ISO 13485 certified, cGMP compliant, UL listed products

Capabilities:

• Medical blow molding (injection stretch blow & injection blow)
• Complete IQ / OQ / PQ and FAI capabilities
• Complete supply chain management
• Injection molding, subassembly and full-service contract manufacturing
• Complete finished goods manufacturing including sterilization management & printing (1-4 colors)

64,000 sq. ft.

Class 8 clean room

73 CNC Swiss machines, 3 wire EDMs, 5 milling machines

FDA registered; ISO 13485 certified

Capabilities:

• Swiss machining
• Wire EDM
• Metal injection molding
• Secondary finishing operations
• Clean room assembly
• Packaging and labeling

72,000 sq. ft. campus, 3 facilities

Class 8 clean rooms

33 molding presses, 6 mold makers

FDA registered, ISO 13485 certified, cGMP compliant

Capabilities:

• Tool maintenance
• Full metrology lab
• Machine shop capabilities
• Molding: single-shot, two-shot, over
• Electromechanical assembly
• Packaging
• Device assembly

135,000 sq. ft.

Class 8 clean room

FDA registered, ISO 13485 certified, cGMP compliant, UL listed products

Capabilities:

• Design, engineering, assembly, manufacturing, and packaging services
• Tubing sets: cut, coil, and banding machine
• Custom kits
• Automated inspection
• Sewn assemblies
• Electromechanical assembly
• Filters
• Surgical laser fibers
• Suture assemblies

45,000 sq. ft.

Class 8 clean rooms

33 molding presses (40 tons - 300 tons)

FDA registered, ISO 13485 certified, cGMP compliant

Capabilities:

• Tooling Center of Excellence
• Molding: two-shot, insert, over
• Complete device assembly & packaging
• Staples manufacturing
• Staples semi- and automated cartridge loading
• Pad printing
• UV/solvent/adhesive bonding, packaging, blister and pouching
• Electromechanical assembly
• Ultrasonic welding
• Statistical process control

50,000 sq. ft.

14,000 sq. ft. ISO Class 8 clean rooms

27 injection molding presses (55 tons – 225 tons)

FDA registered; ISO 13485 certified

Capabilities:

• Injection molding
• Device assembly, packaging, and labelling
• Secondary operations
• Inspection & testing
• Pad printing

72,000 sq. ft

Class 7 and 8 clean rooms

63 molding presses (55 tons – 385 tons)

ISO 13485 certified, ISO 9001

Capabilities:

• Molding: multicomponent, over, insert, two-shot
• Product assembly and packaging
• Dedicated automation cells
• Specializing in round, clear, high-volume parts

120,000 sq. ft.

51 CNC Swiss machines, 3 CNC multi-spindle Swiss machines, conventional and wire EDMs

FDA registered; ISO 13485 certified

Capabilities:

• 4- & 5-axis milling
• Swiss machining
• CNC turning
• Wire & sink EDM
• Grinding
• Laser processing
• Induction welding
• Overmolding
• Heat shrinking
• Laser marking
• Pad printing
• Electropolishing
• Cleaning & passivation

23,000 sq. ft.

EN: ISO 13485:2012/AC:2012, EN: ISO 13485:2016, ISO 13485:2003

Capabilities:

• Turnkey development
• Program management
• Concept generation
• DFM/DFA
• Moldflow/FEA
• Design controls/design history files (DHF)
• Design Verification Testing

196,000 sq. ft.

12 white room CNC machining centers

Two 7,000-ton presses, 4 ram extruders, compression molding presses (8 tons - 40 tons)

ISO certified 13485, ISO 14001, ISO 17025, ISO 9001

Capabilities:

• Extensive materials research capability
• 510(k) submission support