Consulting

---

• Implementation and audits of quality management systems (ISO 13485, MDSAP, cGMP)
• Regulatory affairs guidance (EU regulations MDR/IVDR, FDA 510k/DeNovo)
• Communication with notified bodies and regulatory authorities & support with the certification of medical devices
• Comprehensive practical expertise

Our conviction is:

• A functioning quality management system is an indispensable foundation!
• Well-structured and therefore easy-to-maintain technical documentation is essential!
• Direct communication with notified bodies and authorities is very helpful!

At en.co.tec Consulting Services, the focus is always on:

• Gradually enable your organization to cover core tasks in the area of regulatory affairs.
• Work together on the topic of regulatory affairs.
• Your employees receive discounted access to all training courses offered by our academy, which includes a wide range of training courses, seminars, and even academic programs.
• Cover all regulatory requirements already on the way to market approval.

We support you in this by providing personal guidance to help you build and maintain the necessary skills.

However, our goal is very clear: we want to empower you with our approach to implement viable solutions and thus cover the area of regulatory affairs sustainably and in the long term.

In our opinion, this is the more sustainable and therefore more cost-effective approach in the long term than implementing a standard solution “imposed” from outside.

Our consultants are your guides. They know the way and the risks, and will get you to your destination safely and professionally.

We are committed to your projects! We respond quickly to your requests! We provide you with individual support!