Medical Devices and Combination Products
Strategic development and regulatory support.
Comprehensive technical documentation and risk management.
Borderline Classifications, Notified Body Opinions.
Precision medicine
Bespoke regulatory strategies for biomarker-driven clinical trials.
Regulatory submissions for CDx and targeted therapies.
Advanced therapy medicinal products (ATMPs).
Human Factors Engineering
Design, optimization, and validation of user interfaces and product interactions in line with Design Controls, regulatory requirements and safety standards to ensure usability and patient safety
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Packaging Development
End-to-End Packaging Development.
Optimization and Harmonization.
Sustainability and Life Cycle Thinking.
Our preferred approach to ensuring a robust MDCP development and approval. We join your team as SME right from the outset (or later) and support you all the way to launch and beyond.
You have a project – we take over. We do the project management and execution end-to-end, ensuring the right skills are brought in to deliver on time, on quality and on budget.
From general training on Medical Devices for Pharmaceutical companies to specialized, e.g. MDR, risk management, ISO 13485, UDI, MD software, 21 CFR 820, training for medical device experts.
You have a specific end-goal – we have a solution for you. From mock Article 117 Opinions, audits/due diligence, to building your QMS from scratch, we provide a holistic solution for you, end-to-end.
