Regulatory & planning

Team is 100% focused on medical devices and has been for over 37 years. This means that we intuitively understand many of the challenges and constraints that you face and as a result, weave in our experience and knowledge into your project to ensure it meets your objectives. In addition, our systems and methods are tailored to meet the stringent requirements of the FDA, MHRA and more. We are active members of several international committees and groups to keep up to date with the latest changes in regulations such as ISO, TOPRA and IPAC RS.

Whether you are looking to develop a sustainable injector or need support taking your medical device into production, we can help you plan and deliver your ongoing or anticipated programs of work. We combine this experience with our in-depth expertise in the regulatory landscape to support you in getting your medical technology onto the market.

Industrialization

Supporting your device into production with design for manufacture and assembly.

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Project management

From small feasibility activities or direction-setting exercises to major multi-disciplinary, multi-site developments, our project managers work proactively with you to deliver the best possible project outcome.

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Regulatory support

After 30 years focusing only on medical devices, we have the skills and experience to help you navigate this highly regulated landscape and find a pathway to product approval.

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Sustainability

Analyzing and designing your devices to minimize greenhouse gases and waste and reduce the carbon footprint.

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Wonder how we could help?

Let’s start working together on your next challenge.

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