Medical Device Manufacturing
We are your turnkey contract manufacturing resource for medical device design, development, and end-to-end production.
- ISO 13485 Certified and FDA registered facilities
- Expertise in multi-shot, micro-molding, reel to reel insert molding, and Spinstack ® molding manufacturing
- Verification of Design for Manufacturability (DFM) based on part concept and specification
- Strict manufacturing documentation system supports design record needs and is maintained for the life of the part or assembly
- Validated sterile packaging
- Sampling plans for defect free manufacturing utilizing state of the art QC equipment
- Lean manufacturing practices
- Scientific molding window studies
- Verification process consisting of IQ, OQ, and PQ
- Tooling validation and verification including IQ, OQ, PQ, Cpk, and Gage R & R
- Cross-functional manufacturing teams evaluate potential savings considering design and production options.
- Sealer and testing equipment specifically configured to meet stringent packaging validation requirements
Technical challenges in your product design and engineering process are often multifaceted. A collaborative approach drives the medical device product development process from conceptual thinking to commercial product success.
JunoPacific offers a comprehensive option for turnkey outsourcing -- a medical device product design, engineering and manufacturing team that works with you to meet your medical device development timelines, product design optimization, and budget.
JunoPacific's clients include early stage biotech and life sciences investors, entrepreneurs, physicians launching new concepts, and established biotech companies in California, across the United States, and worldwide. Think of JunoPacific for innovation, experience, results, and collaboration.
Medical Device Development
Defect-free OEM Medical Device Contract Manufacturing
Speed of delivery doesn't mean compromising quality. In fact, the key to JunoPacific' success is evident in our Quality Assurance System that offers:
- Quality Management Systems registered to ISO 13485 as well as ISO 9001 both locally and in partner locations
- CMM and Micro-Vu measurement capabilities
- SPC, Cpk, Gauge R and R, and DOE data available
- Support for IQ/OQ-PQ/PPQ qualification
- From conception through FDA approval, JunoPacific will carefully guard your trade secrets and protect your intellectual property
Medical Device Development
Reaching the Marketplace
When you're ready for distribution, JunoPacific will manage all the assembly and packaging. JunoPacific will assemble your medical device components into finished device products inside one of our clean room facilities. We offer product sterilization and packaging services at our off-site partnership locations. A sample of some of our additional production services includes pad printing, insert and over-molding, assembly, ultrasonic welding, hot stamping, heat staking, testing, stress testing, annealing, bar coding, labeling and packaging.
Meeting tight deadlines and staying within sensitive budgets is crucial from the start of every project. Through continuous improvement efforts such as operational excellence and lean manufacturing, at JunoPacific we strives to continually improve on our already sterling reputation for both accuracy and on-time delivery.