Abstract: There is a misperception that implementing Design Control will restrict innovation, flexibility, and agility of product development. Often perceived as a burdensome regulatory requirement, it is quite the opposite. Implementing a user friendly, simple, and robust “Design Control” process allows a company to not only meet regulations, but to also produce a meaningful device that is reproducible and meets stakeholders needs (including the consumer). To do so, the process requires clear definitions of product attributes, regulatory requirements, communication pathways, and validation. The result is a readable history of the product’s design, rationale, and product-life-long traceability to ensure that corrective actions are taken with continuous improvement. The key for project managers is to maintain all objectives on track, whether it is design, regulatory, costs or delays requirements, and to ensure that all stakeholders are aligned.

With this objective in mind, this poster aims at providing key learning from ISO 13485:2016 and QSR (21 CFR 820) that can be applied to device development intended for PMTA, MRTP, and NNHP submissions.

Lise Fraissinet, Bryan Burd, Kevin Burd, Ed Carmines and Manoj Misra

Affiliations: Chemular, Inc, Hudson, MI, USA