PriMed Instruments Inc. is a contract manufacturer of Class 1, Class 2 and Class 2a reusable and single use medical devices.
Our main focus and expertise are in mechanical devices related to flexible and rigid endoscopy, cardiology and pulmonogy.
We are an FDA registered manufactured, operate under ISO13485:2016 Quality System and comply with cGMP, MDSAP and MDD Directive.
The range of our capabilities includes:
- assembly of precision mechanisms
- ISO Class 8 clean room assembly
- laser welding
- ultrasonic welding
- epoxy dispensing
- ultrasonic cleaning
- labeling and packaging
- fixturing
- device testing
- process validation
- precision mechanical component sourcing
- sterilization sourcing and management
- incoming, in-process and final quality inspection
- SOP, DMR and DHR documentations
These are some examples of custom devices we manufacture:
- Flexible Biopsy Forceps with various jaws configurations, length, flexibility and torqueability.
- Jaws diameter as small as 3Fr
- Endoscopic Grabbers, baskets, probes
- Cytology brushes
- Cleaning brushes for rigid and flexible endoscopes
- Cleaning brushes for ophthalmic devices
- Cardiac and Pulmonary delivery systems
- Endoscope assemblies and sub-assemblies including bending sections and heads
- Industrial flexible retrieval tools, probes and gauges
Whether you are looking for prototypes, pre-market production or volume manufacturing, our experienced management and highly trained and motivated staff are ready to work with you.
Please Contact Us about your requirements. You will find a reliable manufacturing partner for your project.