Our Services
WHAT WE CAN HELP YOU WITH
DESIGN AND DEVELOPMENT
Integrity Research and Development specializes in medical device development. Therefore, we ensure that your design control and QMS requirements are met during the development process. We will work within your QMS boundaries or work with you to develop your own ISO 13485 compliant Quality Management System.
QUALITY ASSURANCE
Integrity Research and Development can do software validation and verification using an independent QA tester. We also will help you build and review your quality management system, providing you with Standard Operating Procedures, work instructions, and all documents required for your compliance to ISO 13485 and Design control, Risk Management and -other required training.
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REGULATORY AFFAIRS
Integrity Research and Development has regulatory affairs specialists that can prepare your FDA and international submissions, do internal audits and provide input into the design and Development process when required or requested. We work with a group of specialists, which allows us to provide expertise for your product.
Specializing in medical devices -
Integrity Research and Development specializes in medical device development. Therefore we ensure that your Design Control and QMS requirements are met during the development process. We will work within your QMS boundaries or work with you to develop your own ISO 13485 compliant Quality Management.
OUR PROCESS WORKS
Whether you are a medical device company or a consumer product, energy, industrial, etc. Company, our process is designed to provide you with an efficient, cost effective, successful income.
GLOBAL TEAMS
Your project will be managed by development managers in the United States. Your regulatory expert will be based in the United States. We use development teams around the world, including the United States, but also globally, that have the specific expertise you are looking for. Once we have an idea what your biggest challenges are in your project, we will work with you to build the best team for your needs. Our teams support each other, so that you get the optimal solution.