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A quality management system (QMS) is a substantial part of any successful business.  Gone are the days where all a firm needed was a high performing sales and marketing team or the most cost effective product on the market.  Clients today are more business savvy and demand their suppliers establish, implement, and maintain those processes and systems that will guarantee the on-going availability and consistent quality of purchased product.

A quality management system (QMS) also demonstrates a firm’s commitment within a regulated industry to meeting regulatory authority requirements throughout the national regions where it desires to commercialize its products.  It is this established and oftentimes certified compliance to meeting regulatory authority requirements in conjunction with regulatory authority approval (or clearance) that allows a firm place its products on the market.

If you are thinking your quality management system (QMS) is beginning to resemble a Rube Goldberg machine1, Wicked QMS can help.  If your QMS is just plain broken, Wicked QMS can help.  If you need a QMS and don’t know where to begin, Wicked QMS can help.  Wicked QMS can help your firm establish and maintain compliance to the following domestic and international regulations, directives, and standards:

  • 21 CFR Part 820 (FDA Quality System Regulation)
  • Canadian Medical Devices Regulation (SOR 98/282 — Part 1)
  • Regulation (EU) 2017/745 of the European Parliamant and of the Council of April 2017 on Medical Devices
  • Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices
  • ISO 13485:2003, Medical devices — Quality Management Systems — Requirements for Regulatory Purposes
  • ISO 13485:2016, Medical devices — Quality Management Systems — Requirements for Regulatory Purposes
  • ISO 9001:2015, Quality Management Systems — Requirements

Richard Welch | Owner & Principal Consultant

1 Rube Goldberg machine – a deliberately complex contraption in which a series of devices that perform simple tasks are linked together to produce a domino effect in which activating one device triggers the next device in the sequence.  Over the years, the expression has expanded to mean any confusing or complicated system.  Wikipedia

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