Doug Silber of Silber Business Solutions has partnered with me in developing quality system procedures compliant to the Quality System Regulations and ISO 13485 standards for start-up medical device companies. In particular, in 2012, Doug worked directly with the management staff of a particular medical device company in creating the foundation for their quality system. At the time Doug was developing the quality system, the company was in the early stages of product development for an innovative device. Two years later, the medical device firm is in the process of bringing their device to market and his quality system foundation is firmly in place and expanding to meet the needs of the customer. I would recommend Silber Business Solutions for development of quality systems which are in compliance with US FDA regulations and ISO 13485 standards for medical devices.
- Mark L. Friedman, Ph.D. President of MM&A Consulting, LLC, Lake Butler, Florida
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