KJR LIMITED

Welcome to the KJR Limited.
We are a Regulatory affairs and Quality assurance consultancy for the medical device sector.
We advise companies on the best ways of getting products to market by navigating the worlds medical device regulations, directives, standards and guidelines.
Our expertise in the two branches of Regulatory affairs and Quality assurance combine to help you get your products to market in efficient, effective and repeatable ways.
Through our knowledge of international Regulatory affairs we can help you prepare the necessary paperwork and submit this paperwork to the regulators of your target markets.
Our knowledge of quality management systems can help create and/or improve your processes and procedures so that the activities needed to meet the regulations in your target markets will be performed systematically, making your submissions more efficient.
KJR Limited specialises in high-tech, digital and software medical devices and we can offer the following areas of expertise to help you.
• Quality management systems
• Design and development processes
• Risk/safety assessment
• Supplier approval/surveillance
• Usability
• Clinical evaluation
• Market submission
• Technical file remediation
• Quality excellence model
For full details of the services that we offer please contact us directly.
Rest assured that our solutions will be specifically tailored to your needs.

Company’s Keywords:

regulatory affairs, software, medical devices, quality assurance, outsource supplier management, process approval