Testing & de-risking

Whether you need to conduct device verification testing, effective due diligence or are considering licensing a device to deliver your therapy, our experience gives us a rich understanding of what it takes to acquire and develop a commercially viable, technically robust and compliant medical product.

We combine our know-how with our state-of-the-art labs, workshop facilities, and equipment to support you with your device testing needs. When it comes to testing, we don’t believe in “one size fits all solutions.” We interpret the latest industry standards and guidance, then add our own broad expertise to arrive at a solution that suits your needs. Whether our support starts with testing to prove concepts, defining requirements before embarking on the design verification journey or investigating a marketed product, the device testing team always provides an objective and independent view.

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Design verification testing

We plan and deliver comprehensive Design Verification Testing (DVT) programs to support your submission.

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Medical device due diligence

From assessments of organizational structure or manufacturing capability to gap analysis on technical and Design History Files (DHF), we provide a highly effective source of independent and expert review.

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Medical device testing

Our device testing team finds the right testing solutions no matter where you are on the product development journey.

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Quality engineering

We ensure that our collaborations are based on aligned quality management systems and comply with all relevant regulations.

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Risk management

Risk management is at the heart of medical device development and a constant thread through our activities and goes beyond the application of ISO 14971. Risk-based approaches guide everything we do.

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Technical audit

Applying a range of tools and processes to ensure that the product or technology that you are interested in is fully assessed against your requirements.

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Wonder how we could help?

Let’s start working together on your next challenge.