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 tissue acquisition devices, grabbers and graspers, probes, advanced catheters, advanced delivery systems, flushing/suction devices, cytology and cleaning brushes.
We operate in accordance with ISO13485:2016 Quality System and are pleased to offer the following assistance:
- conceptual work
- review of relevant technologies
- design planning
- design inputs
- design output
- design review
- design verification
- design validation
- design change control
- design transfer to manufacturing
- 3D CAD design
- Detailed engineering drawings
- Documentation, such as SOPs, DMRs, and Technical File for CE Mark
- Intellectual property assistance and licensing
- Regulatory strategies and compliance
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.
Contact us at: engineering@primedENDO.com