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 lie in mechanical devices related to flexible and rigid endoscopy, cardiology and pulmonology. We are an FDA-registered manufactured, operate under ISO13485:2016 Quality System and comply with cGMP, MDSAP and MDD Directive.
Our manufacturing capabilities range includes:
- Assembly of precision mechanisms
- ISO class 8 clean room assembly
- Laser welding
- Pneumatic crimping
- Precision soldering and brazing
- Ultrasonic welding
- Epoxy dispensing
- Ultrasonic cleaning
- Pad printing
- Own brand labeling and packaging
- Jigs, fixturing and semi-automation
- Precision mechanical component sourcing
- Sterilization sourcing and management
- Assembly process validation including IQ, OQ & PQ
- Incoming, in-process and final quality inspection
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 (1.0mm)
- 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
- Flushing device for irrigation and aspiration of GI track
Whether you require prototypes, pre-market production or volume manufacturing, our experienced management and highly trained, motivated staff are ready to collaborate with you. Please Contact Us regarding your requirements. You will find a reliable manufacturing partner for your project.
PriMed Instruments Inc. management and engineering staff are qualified and experienced in the Design & Development of single use and reusable medical devices, including device labeling, packaging and sterilization. Since the inception of the company our focus was to develop and manufacture high quality therapeutic and non-therapeutic medical devices related to flexible endoscopy.
We specialize in the design and development of tissue acquisition devices, grabbers and graspers, probes, advanced catheters, advanced delivery systems, flushing/suction devices, cytology, and cleaning brushes.
Our product development strategy consist of the following stages:
- Identification of a need for new or improved device; internal or external
- Initial conceptualization (3D CAD design using SolidWorks Pro, Additive Manufacturing Prototype, quick product and production mock-up) and check if the product is a good match for us.
- Business and Legal Considerations
- Intellectual property assistance and licensing
- Regulatory strategies and compliance
- Review of relevant technologies
- Design Planning (design control documentation)
- Design Inputs (customer & regulatory requirements, risk management output, study results)
- Design Output (device itself, detailed engineering drawings, product specs, technical file)
- Design Review (outputs meet inputs, FMEA, DHF)
- Design Verification (fit and function, force gauge testing, sterility, bio-comp, transit & stability test)
- Design Validation (functional testing, simulated use, animal testing, clinical trial)
- Design Change Control
- Design Transfer to Manufacturing (from small production run to large semi-automated line)
- Documentation such as SOPs, DHR/DHF, DMR/MDF, PMSP, PSUR, and Technical File for CE Mark
You can benefit from our knowledge and experience in mechanical engineering and industrial design of medical devices. You will significantly reduce the development and design costs, as well as, accelerate the introduction of new products to the market.
Whether you seek prototypes, pre-market production, or volume manufacturing, our experienced management and highly trained, motivated staff are ready to work with you. Please Contact Us about your requirements. You will find a reliable design and development partner for your project.