Jalex Medical

medical device design, product development & regulatory consulting: bringing medical advancements to market design & development - concept generation and 2d/3d cad - medical device design per fda regulations - finite element analysis - find manufacturing resources to create prototypes and production parts quality - quality management system development and implementation per 21 cfr 820 - iso 13485, fda, mdd, and canadian directive general and facility specific training programs - company representative during external audits by regulatory and third party auditors - fda remediation assistance for 483 observations and warning letters regulatory - regulatory path assistance & product classifications (class i, ii, iii) - 510(k) submissions - predicate device research - device/instrument registration & listing