Quality & Regulatory Compliance

Quality and Compliance That Keep Innovation Moving

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.

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Quality & Regulatory Expertise

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

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Healthcare product verification programs

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Implementation of manufacturing QMS

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Healthcare usability studies

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Collecting data for design history file

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Case Studies

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 use error from drug performance. This allows developers to focus investment correctly, reduce costs and accelerate a new treatment’s journey to market.

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Case Studies

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.

Capabilities

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Sustainable & Circular Design

With extensive industry experience and a focus on technological advancements, we offer insights that drive progress towards sustainability goals.

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Product Strategy & Innovation

Creating the data, analysis and strategies for evidence based innovation decisions

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Human-Centered Design

Creating compelling user experiences for brands, packaging, products and services.

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Electronics & Software Engineering

World class digital and data innovation for the consumer, healthcare and industrial sectors, from concept to global launch.

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Manufacturing Engineering & Industrialization

Engineering and management creating a seamless transition from prototype to mass production for rapid launch

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Design Verification & Test Engineering

Prototyping and lab testing new products. Innovating while meeting regulatory standards. Proving performance at speed.

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Mechanical & Industrial Design Engineering

Transforming concepts and new technology into breakthrough manufactured products

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Quality & Regulatory Compliance

Meeting the requirements of regulators around the world

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Applied Science & Technology Development

Applying scientific rigor to create robust product technologies

“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

CONTACT CAROLINE

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