DESIGN AND DEVELOPMENT
Getting Started
Integrity Research and Development strives to provide you with an alternative to your development needs. We partner with you at any stage of the development process, providing services you need to be successful.
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.