REC MD Consulting – Ensuring Compliance with MDR and FDA
Do you need support to ensure compliance for your medical devices or for your company?
My offer is specialized consulting for quality management and technical documentation to optimize your processes and meet regulatory requirements. I assist you in digitalizing documentation and processes and help with the implementation of new software applications.
My Expertise and Passion: Regulatory Affairs for Medical Devices.
Regina Preysing
Your consultant for regulatory affairs in medical technology. Ensuring the compliance of your products and processes—simple and structured.
Compliance for Products and Processes through Tailored Consulting
REC MD offers customized consulting services for medical device manufacturers to ensure regulatory compliance. I help you optimize your quality management system and successfully develop your products.
Quality Management
My approach: Processes should support employees in successfully carrying out their tasks. A QMS should help management maintain oversight and make informed decisions.
Product Development
In product development, I focus on structure and traceability – from requirements through validation to production – to ensure clarity on the development status throughout the entire lifecycle.
Technical Documentation
Documentation should emerge naturally from the developers’ work, in coordination with product managers and quality management. Digitalization is now essential here. I support you in selecting, implementing, and utilizing digital applications.
Individual Consulting
Every company is unique—startups have different priorities than established manufacturers. Regulatory requirements are constantly evolving, and new technologies and tools demand attention and need to be implemented. Together, we will find your solution for these challenges.
