Consulting for Topics Related to Integration of Requirements according to 21 CFR Part 11 and ISO 13485

Are you looking to elevate your software development to the next level by incorporating 21 CFR Part 11 features? With our extensive experience and specialized consulting, we are here to assist you and provide practical guidance and support!

Our team consists of experienced consultants who are not only familiar with the intricacies of 21 CFR Part 11 but also come from software development backgrounds themselves. We have firsthand knowledge of the challenges and opportunities the industry presents and offer practical solutions to optimize your operations while ensuring compliance with all standard requirements.

Our solutions have been in the market for years and are continuously evolving. From evaluating your current processes to implementing new strategies, we stand by your side. Our tailored solutions are specifically designed to meet your needs, giving you the confidence that you’re on the right track.

Additionally, we can provide support for additional services such as maintenance or IQ/OQ. This offering does not claim to provide comprehensive consulting on the topic of 21 CFR Part 11. Rather, it is meant to offer practical assistance in addressing specific questions and aiding in their resolution.

Consulting for Topics Related to Integration of ISO 13485

As an ISO 13485-certified company, we have undergone the process of implementing the QMS and SOP and have experienced various audits. Our approach involved a highly practical and fully digital implementation of the QMS.

We are happy to share our experiences through a workshop and present our solution. Using practical topics, we explain the key points from our experience that were significant.

This consulting service does not claim to cover purely legal aspects of ISO 13485, nor can we provide detailed answers to specific questions. Our offering focuses more on practical aspects of implementation and interpretation in the software segment.