OUR PROCESS
No matter how complex, Putnam Medical is here to help advise with new device concepts and assist with development of your medical device needs. With decades of experience in creating industry leading medical technology solutions with our partners, our team of highly skilled engineers offer the most comprehensive medical device development services in the industry. From start-ups to Fortune 500 companies, we’ve partnered with them all- bringing the most innovative devices to market. Putnam Medical specializes in catheter and devices requiring advanced technologies.
VERIFICATION & VALIDATION
Putnam’s thorough verification and validation testing provides our partners with peace of mind when it comes to the functionality and reliability of our products. To assure your product is manufactured in a controlled environment, processes and machinery are validated by our team of expert quality control engineers. All processes are properly validated in accordance to ISO 13485 and FDA regulations and are suitable for your regulatory submission.
Our internal capabilities include but are not limited to:
- ​Prototype development
- Equipment, Tooling, Equipment Validation (IQ)
- DOE (Design of Experiments)
- Assembly and Process Qualifications and Validations (OQ, PQ)
- Packaging and Validation
- pFMEA (Process Failure Mode and Effects Analysis)
- Statistical Analysis and Reporting (Quality Engineering)
- Supply chain management for extrusion and molded components
We work with outside partners for:
- Product and Packaging Functional Testing
- Shelf-life Studies (Accelerated and Real Time)
- Sterilization Validation (to be outsourced)
PILOT PRODUCTION
Validating any new process comes with a bit of risk. In order to minimize risk and test the manufacturing process, running a small volume pilot production is extremely useful. This helps ensure any kinks are worked out before going into full production.
