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Services

We are committed to ensuring the success of your projects by providing guidance on product development, implementing Quality Management Systems meeting ISO 13485 standards, offering regulatory consultancy for Technical Documentation and Clinical Evaluations compliant with MDR and IVDR, and providing comprehensive support for EU clinical trials.

Quality Services

We offer customized regulatory and quality solutions designed for medical device companies.

Clinical Services for MedTech

We provide end-to-end support covering each step of a clinical investigation, from First In Human (FIH) to observational registries.

Clinical Services for Biotech & Pharma

We support companies through every stage of clinical development, offering tailored solutions that streamline regulatory pathways and accelerate the launch of safe, effective therapeutics.

Regulatory Services

We offer customized regulatory and quality solutions designed for medical device companies.

Post-Market Services​

Providing a comprehensive post-market support to ensure regulatory compliance and enhance the safety and performance of your medical device throughout its lifecycle.

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