Regulatory consulting and compliance strategy for MDCP
Design, planning and execution of compliance strategies for EU MDR, including Article 117 Notified Body Opinions.
Packaging Development
Packaging design strategy, harmonization & optimization in line with Design Controls, regulatory requirements and sustainability goals.
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
Carsten specializes in information security auditing, IT systems and product identification and traceability to ensure regulatory compliance and correct handling of critical business data.
