SSCPs Are Not Labeling: Compliant AI Processes for Reduced Cost & Turnaround
In this fireside chat, TransPerfect Medical Device's President Marc Miller sits down with Dr. Keith Morel, VP of Regulatory Compliance at Qserve, to unpack a critical question facing medical device manufacturers under MDR: can you reduce the translation review process for SSCPs without running afoul of regulators? Dr. Morel walks through a detailed regulatory risk analysis, explaining why translation errors in SSCPs are unlikely to trigger a Field Safety Corrective Action and more likely to result in a straightforward "fix it" ticket under Article 97. With SSCPs routinely running +50–120 pages and requiring translation into 20+ languages, the cost implications are significant, and this conversation offers a practical, expert-backed framework for managing them.
