DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Statistical Techniques for Medical Device Manufacturers" conference to their offering.
The FDA's Quality System Regulation (QSR) requires device manufacturers to identify valid statistical techniques to "establish, control, and verify the acceptability of process capability and product characteristics". When device manufacturers analyze CA & PA information, they must also use "appropriate statistical methodology". In addition, sampling plans must be valid, documented, adequate, and reviewed based on changes.
Some manufacturers are not clear about all of this. Others are nervous about creating a sufficient approach to make good decisions and satisfy the regulations. The result may be a patchwork of techniques without a coherent methodology. This workshop helps resolve the problem.
- The workshop starts with an understanding of the regulations including QSR, ISO 13485:2003, and ISO 13485:2016. It also includes the methods regulators use to check compliance including the Quality System Inspection Technique (QSIT), FDA Warning Letters, and the Medical Device Single Audit Program (MDSAP).
- The FDA regulations don't provide a catalog of available techniques or their application. This is the role of ISO/TR 10017:2003 Guidance on statistical techniques for ISO 9001:2000. While this guidance was written for ISO 9001:2000, it is easily applicable to FDA QSR, ISO 13485:2003, and ISO 13485:2016.
- The guidance document provides a list of statistical techniques and explains how each applies to particular ISO 9001:2003 clauses. Mapping these applications to FDA QSR, ISO 13485:2003, and ISO 13485:2016 is straightforward and provides a robust approach to help a manufacturer identify the appropriate methods.
- The workshop explains the many of the techniques, shows how they apply using medical device examples, and includes exercises for participants to solidify understanding.
For more information about this conference visit http://www.researchandmarkets.com/research/fbg8mn/statistical