Team expertise

Quality & Regulatory Affairs

Meeting the requirements of regulators around the world. Quality and regulatory planning and implementation

  • 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)
  • Quality management systems under ISO 13485 and ISO 9001
  • 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 and ISO 9001. 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.

Top:

Top Left:

Healthcare product verification programs

Center Left:

Top Right:

Implementation of manufacturing QMS

Center Right:

Bottom Left:

Healthcare usability studies

Bottom:

Bottom Right:

Collecting data for design history file

Quantii

Multi-application sensor platform to analyze patient behaviour

Drug delivery devices can be notoriously tricky to use, so our technology enables improved studies that can distinguish user error from drug performance. This allows developers to focus investment correctly, reduce costs and accelerate a new treatment’s journey to market.

“Finding the most effective regulatory pathway for your new product is a complex task. Our experience will help get your innovation to market fast”

Caroline Marshall

Consultant Quality Engineer

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Pelikan Technologies

Low pain lancing system for diabetics

The aim was to disrupt the diagnostics market with a lancing system that would significantly improve the patient’s experience. Our development and regulatory teams helped our client launch the first FDA & CE approved device for fully automated, virtually pain-free lancing.

INNOVATION/Insights
Analysis:
The key to FemTech success? Forget about the tech

9 Jul 2021

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Analysis:
When is “clinical software” not “software as a medical device”?

13 Apr 2021

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Analysis:
ISO 11608: All change for injector standards

1 Apr 2021

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SEE ALL INSIGHTS