True North Consulting Kft

With over 10 years of experience True North has helped medical manufacturers achieve US and European regulatory approval and quality compliance for medical software products. Whether you're thinking of introducing medical software into a new market or maintaining regulatory compliance in an existing market, True North will drive the effort to overcome the regulatory challenges. Some of the services True North provides- End-to-end leadership and guidance through EU MDR and FDA regulatory and quality compliance - Performing analysis to identify gaps in complying with applicable guidances, regulations and international standards (e.g: ISO 13485, ISO 14971, ISO 62366, IEC 62304, AAMI TIR 45, ISO 15223-1, ISO 20417)- Development of Quality Management Systems (QMS)- Development of the Software Development Life Cycle (SDLC) using Agile and Waterfall methodologies - Development of Standard Operating Procedures (SOP)- Compiling regulatory submissions (Technical documentation for CE Marking, 510(k)) Contact us for a free consultation to discuss your needs.