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).
It is Child’s Safety Week from June 7 – June 13 2021 and we would like to raise awareness for this very important topic as well. This year’s slogan of the event “Share because you care” is why we would like to share our knowledge with you.
In our last article, we discussed the confusing situation regarding remote audits and the strategies that manufacturers can follow in order to qualify for this type of inspection under the MDR. In this article we focus on analysing Notified Bodies’ experience while conducting remote audits under the MDD and giving you practical advice for successfully going through it and try to devise the future of remote audits.