Regulatory consulting and compliance strategy for MDCP
Design, planning and execution of compliance strategies for EU MDR, including Article 117 Notified Body Opinions.
Packaging design, anti-counterfeiting and engineering
Packaging engineering and design of MDCP in line with Design Controls, regulatory and user requirements.
Data & Digital
IT project management, consulting on data governance and strategy, independent data privacy and information security reviews and audits.
Carsten specializes in information security auditing, IT systems and product identification and traceability to ensure regulatory compliance and correct handling of critical business data.
Juan specializes on end-to-end regulatory compliance projects for medical devices and combination products (EU MDR, EU/US UDI).
Unique Device Identification (UDI) systems are arising worldwide, and understanding similarities and differences between them is key to be able to meet the requirements for each specific country or region.