Quality & Regulatory Affairs

• Regulatory standards analysis & requirements capture
• Regulatory reviews (MDR/IVDR/MDSAP)
• Device risk management (ISO 14971)
• Usability & human factors studies (IEC 62366)
• Medical device software reviews (IEC 62304)
• QMS ISO 13485:2016 by Intertek Medical Notified Body
• QMS ISO 9001:2015 by Intertek Certification Ltd
• Design history file/technical file creation & remediation

There’s a rush that comes with innovation – the excitement over fresh ideas, the buzz of collaboration, the thrill of a launch. But that all hinges on quality products that work reliably, safely, and within regulatory requirements. CDP has you covered.

Our seasoned Quality and Regulatory experts bring experience in the medical device, diagnostic, and consumer product industries. We offer specialized expertise in Human Factors, Software Regulation, Design History File Remediation, and Device Verification Testing.

Our business and clients are global, while we work to local regulations as required and the latest FDA guidelines. Our Quality Management System is certified to ISO 13485:2016 by Intertek Medical Notified Body and ISO 9001:2015 by Intertek Certification Ltd. Our teams also provide advice on Regulatory Strategy and the Quality Management Processes needed to launch new products in a way that’s compliant and time efficient. In other words, no detail escapes our thorough process, and we’ll get you to market on time. But the support doesn’t end there: We provide ongoing training and auditing, keeping you at the top of your game.