MIDI is proud to announce that we have successfully transitioned our Quality Management System from FDA Quality System Regulation to FDA Quality Management System Regulation in advance of the FDA’s enforcement date of February 2, 2026. This proactive milestone reflects our long-standing commitment to regulatory rigor, continuous improvement and alignment with global best practices. By completing this transition early, MIDI has fully integrated the FDA’s harmonized framework, which aligns closely with ISO 13485:2016 and emphasizes risk-based thinking, lifecycle management and clearer integration of quality into design and development activities.
For our clients, this transition delivers immediate and practical benefits across medical device and SaMD development programs. Projects executed under MIDI’s updated QMSR-aligned system benefit from streamlined design controls, stronger traceability and reduced regulatory friction when moving from development into verification, validation, and commercialization. Ultimately, this positions our partners for smoother FDA interactions, fewer late-stage quality surprises, and development programs that are better structured for both US and global regulatory success.
MIDI is looking forward to attending Advanced Therapies Week, in San Diego from February 9–12, 2026.
This event serves as an important platform for exploring the future of advanced therapies and discussing innovative solutions shaping the industry. We’ll be sharing insights into our advanced bioprocessing instrumentation, disposables and system architecture expertise and how we help organizations achieve their therapeutic development goals efficiently and effectively.
Let’s Connect!
We’re eager to meet with attendees during the event to discuss opportunities for collaboration and innovation. Visit our Bioprocessing Expertise Page to learn more and schedule a meeting with our team. Schedule a Meeting
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