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Medical Device expert specializing in development of efficient Quality Systems for small and startup medical device companies. Rose works as a the contract Quality Manager for multiple medical device companies overseeing overall quality strategy and ensuring compliance through documentation and auditing services. Rose is a certified quality auditor (CQA) and has regulatory and submission experience for a variety of markets including FDA, CE Mark, Health Canada, and CFDA. Rose encourages the simplification of Quality Systems to reduce the quality burden and improve compliance through training and efficient QMS design.
At Minitab, we conduct extensive internal testing to maintain the highest quality of our software products.
Next, you should create a team to evaluate which pieces of software are being used in the quality system and evaluate the risk of each of those applicable pieces of software.
This assessment can include Excel spreadsheets, databases, Solidworks/CAD files for design activities, issue tracking software, complaint management software or CRM systems, PLM systems, ERP systems, and/or distribution software programs.
We are estimating that about 3-6 months of consulting work is required in order to get our new companies audit-ready.