Your partner in
Quality & Regulatory Compliance.

We're ready to serve.

Vision & Mission

A Global Leader in Quality Assurance and Regulatory Compliance, collaborating with businesses developing pioneering medical technology and innovative products.

Providing an end to end service, collaborating with customers, developing a strategy to suit your unique needs, whilst demystifying the compliance process

What we do

We have over 10 years' experience in Quality Assurance and Regulatory Affairs for Medical Devices, Cosmetics and medicinal products, from design and development through to manufacture, market release and post-market support. We have your needs covered.

Regulatory strategy, implementation and support

Whether you are an established device company, start-up or entrepreneur with a world-changing idea, the regulatory framework for our industry is rapidly changing and the implication will impact us all.

Quality Management Systems

A product of consistently high quality is the result of interrelated, interconnected processes. Our understanding of these processes and their implementation will provide your business with the control it requires to ensure compliant output and continuous improvement.

Risk management processes and usability engineering

Risk management is the single most important part of any medical device development. Taking into account the design, use, production, the supply of your product, it under unpins the quality management system.

Project Management

Every successful project starts with the end in mind, the breakdown of tasks to achieve it and milestones to keep it on track. Our project managers are qualified in Prince2 and have worked on a range of projects to successful completion managing variables such as time, budget and external partners.

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Work With Us

Our team have vast experience implementing a range of national and international standards and regulatory requirements across the healthcare industry. Whether it's an MDR 2017/745 or IVDR 2017/746 strategy you need, a compliant quality management system or a product test plan, or support in the design and development of your device, we can help.

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