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adjutem is your partner in regulatory affairs and product realization for medical devices.

Navigate the complex regulatory landscapes of the EU, US, and Asia with ease. Our specialized consulting team, focused on medical devices and in vitro diagnostics, provides tailored solutions.

Whether you’re launching a new device or expanding into new markets, our experts will guide you through every step, from regulatory strategy to submission and approval.

With more than 10 years of experience and numerous projects in Europe, Asia and the US, we’ve built a solid reputation for delivering results.

From start-ups to established companies, we’ve helped clients achieve market entry swiftly and efficiently, ensuring compliance and accelerating success.

Our modular consulting approach offers flexible, targeted support at every stage of your medical device development and product lifecycle:

When you need assistance with regulatory strategy, clinical or performance evaluation, quality management, or post-market surveillance, our services are designed to integrate seamlessly into your project.

	We typically follow our standardized 5-phases process model for device development where we focus on regulatory compliance, risk management and usability. This model is flexible and can be adjusted to customer needs and complies with specific MDR, IVDR or other regulatory frameworks. Choose only the modules you need for your product, or opt for full support from concept to market. Let us help you accelerate your path to market success while minimizing risks.

Together with our business partners we can offer a full coverage of product realization activities including development, production and regulatory services.

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