Tim Smith Consulting Inc.

They say practice makes perfect. But what if that practice is based on ineffective process design, specification variance, and other slight inconsistencies? In that case, no amount of practice can perfect the outcome for patients. As engineers, designers, and manufacturing operations specialists, we have witnessed first-hand the impact of leaving the results to chance. We put our in-depth industry experience to work for medical device companies to make predictability the norm through product-critical process control/validation, equipment IQ/OQ/PQ, measurable performance, and continuous improvement.

Company’s Keywords:

sdlc, equipment iqoqpq, medical device validation, cfr part 11, six sigma methodologies, lean manufacturing, manufacturing process validation, fea, risk mitigation, capa, quality management systems, new product introductions, good modeling practices, quality assurance, operational excellence, cgmp compliance