Founded in Ontario, Canada, in 1995, PriMed Instruments Inc. has focused on developing innovative therapeutic and non-therapeutic medical devices for flexible endoscopy and medical device reprocessing. Our key offerings include the MultiCROC® Single Use Multi-sampling Biopsy Forceps, along with a range of Reusable and Disposable Cleaning Brushes, notably featuring the novel and validated Channel Cleaning Device - SuperDART®. All our products are designed, developed, and manufactured in-house in Ontario, adhering to stringent Quality System standards and backed by a strong Intellectual Property portfolio.

Beyond our core products, PriMed Instruments Inc. specializes in private labeling, Contract Design & Development, and Contract Manufacturing of custom medical and industrial devices. Leveraging our expertise, we aim to be your reliable partner for single-use and reusable medical devices, as well as industrial endoscopy tools.

The quality of the products we develop, design and manufacture is assured by the management commitment to the stringent compliance with one or more of the following Quality Systems:

MDSAP ISO13485:2016
FDA 21 CFR 820/801/803/830
EU MDR 2017/745

All our devices are manufactured under rigorous quality control including routine statistical inspection in accordance with ISO 2895-1 at incoming, in-process and final stage of production.

  • Based on our knowledge and experience we can assist you in a practical way in the following areas:
  • Design of your Quality System
  • Strategies to cost effectively implement your Quality System
  • Regulatory compliance for US, Canada, and Europe
  • Technical File for CE Mark
  • Device Master Records (DMR) for cGMP
  • Writing procedures and instructions
  • Validation Management
  • ISO standards for biocompatibility, packaging, sterilization, shipping/distribution and other related standards
  • Internal audits
  • Preparation for a certification audit

Please Contact Us regarding your requirements. You will find a reliable partner for your quality system or quality assurance project.

ISO CERTIFICATE PDF CONTACT US