You can count on us for medical implant and device product development from a single-source for contract manufacturing. Our highly specialized team of medical devices and implants engineers, designers, machinists and toolmakers working together will serve as a vital extension of your team. We’ll support you, moving swiftly and precisely from concept through design for manufacturability, development and delivery, all while meeting critical regulatory requirements, schedules and budgets. Our medical device contract manufacturing engineers help you select the best polymers and metals to bring manufacturability, accuracy and consistency to your molded components. In addition our medical implant and device development engineers are experienced with exotic materials, including high temperature, implantable grade materials and silicone. Our subject experts are proficient in Class I, II and III devices. We offer the following services from an FDA registered, 21 CFR 820 compliant, ISO 13485 certified, Good Manufacturing Practice (GMP) compliant facility:

​

• Medical implants & devices design and optimization using advanced software and simulation

• Raw material and components selection and consolidation

• Design for Six Sigma (DFSS) & Design for Manufacturing (DFM) & Design for Assembly (DFA)

• CAD/CAM/CAE

• Moldflow / Moldcool analysis

• FMEA

• ISO certified cleanrooms and cleanroom prototyping & production cells

• Rapid prototyping / Rapid tooling: We produce near-net shape parts with near production tolerances, machined or molded and assembled, in as little as a few days. A large number of secondary operations are available

• Reverse engineering

• Extensive test facility with state of the art instrumentation for physical, mechanical, chemical, electrical, optical and environmental testing and inspection

• Product certification consulting and assistance

• Expert witness and litigation services

• Consulting services tailored to your needs

• Production runs if desired

• Document preparation

• Training services

 

Our turnkey medical rapid tooling and rapid prototyping & manufacturing services also include post-molding machining for undercuts and threads, as well as secondary operations, such as medical bonding and welding, pad printing, decorating and annealing. We can produce high precision micro-molded, insert and over-molded components. AGS-Engineering micro molding processes are capable to achieve extremely tight tolerances and manufacturing critical components that weigh less than 1 mg. Our medical grade liquid silicone molding is performed in an ISO 7 (class 10,000) cleanroom and state of the art inspection and test equipment. Parts and products are processed with automated part handling systems when needed. Our full-service precision medical machining capabilities include:

​

• Multi-axis CNC machining, Swiss-type turning and vertical milling

• Wire EDM

• Cleaning, finishing and secondary operations

 

Medical device machining includes all implantable-grade materials, including stainless steel, titanium, MP35N, nitinol, PEEK, other specialty metals & alloys and plastics.

 

Some of our secondary operations are:

• Medical welding of plastic and metal using resistance welding, ultrasonic and laser welding

• Medical grade bonding using solvents, medical adhesives and UV curing

• Decorating – pad printing, hot stamping

• Laser marking

• Surface coating

• Surface conditioning, modification, functionalization

• Medical cleaning and sterilization using a variety of techniques such as ultrasonic bath, plasma surface cleaning…etc.

 

Your prototypes and products can be assembled and packaged according to medical standards. Our contract medical device assembly and packaging capabilities include:

• Manual and fully automated assembly solutions

• Packaging materials selection and consolidation, supply chain management

• Off-shelf and custom packaging design & development to meet your unique requirements

• Tray & pouch and impulse sealing

• Label printing

• Auto bagging with in-line printing

• Barcode printing and verification

• Leak testing

• Sterilization management

• Data analysis and reporting

 

If you are mostly interested in our general manufacturing capabilities instead of engineering capabilities, we recommend you to visit our custom manufacturing site http://www.agstech.net

​

Our FDA and CE approved medical products can be found on our medical products, consumables and equipment site http://www.agsmedical.com