Parker’s Medical Systems Division is a single source FDA registered and ISO 13485 certified finished medical device engineering & manufacturing firm, offering single use devices, non-sterile reusable devices and in-vitro diagnostic assembly, testing, packaging, sterilization and distribution.
Class I, II and III medical devices:
- Critical Care
- Cardiology
- Operating Room
- Cardiac Cath Lab
- Respiratory Therapy
- Emergency Room
- Neurology
- Oncology
- Labor and Delivery
- Chronic Care
- Clinical Laboratory
- Sleep Labs
- Audiology
Assembly processes include:
- Ultra-precision, precision & standard assembly
- Electro-mechanical assembly
- Catheter assembly
- Nitinol wire forming
- Thermal tip forming
- Solvent & cyanoacrylate bonding
- UV adhesive, epoxy & polymer adhesive bonding
- P.C. board assembly
- Precision & standard soldering
- Fiber optic processing including lens forming & polishing, bonding, gapping, cladding, polishing & fiber pyrolizing
- Flow, leak & tensile testing
- Glass forming
- Controlled siliconizing & silicone dispersion coating
- Gold wire bonding
- Hermetic seam welding
- Electro-static bonding
- Ultra-sonic welding
- Thermal welding & staking
- Micro riveting
- Micro arc welding
- Ultra-sonic cleaning
- Automatic & semi-automatic software controlled testing
- Electro-mechanical testing
- Packaging including pouch, pre-formed trays & form-fill-seal
- Sterilization including ethylene oxide & irradiation
Front End Design Assistance
- Design for manufacturability analysis
- Plastic part design
- Material selection
- Rapid prototyping
- Prototype injection molds for low cost design verification
- Sterile package design
- Shelf and shipping box design and configuration
Process Development and Validation
- Assembly process definition and design
- Test procedure definition and design
- Tooling and fixture design and fabrication
- Equipment validations including I/Q, O/Q and P/Q
- Design of Experiment
- Validation protocol development, testing and reports
- Sterile package seal strength characterization
- Sterilization validation
- Accelerated age studies
- Transit testing
Material Procurement and Control
- Vendor identification
- MRP inventory management
- Component purchasing
- Receiving inspection
- Component and sub-assembly warehousing
- Full lot control
Product Manufacturing
- Full lot control and/or serialization
- In-process and final quality assurance
- Sterile packaging in all standard formats
- Sterilization coordination including QDA's and annual EO revalidations
- Final packaging
Device History Record/Master Record
- Complete device manufacturing documentation
- Complete work order history
- Full lot control