S & W Quality Associates LLC

medical device consulting firm.  qsr & iso 13485 auditing  supplier auditing  due diligence audits  design controls  capa implementation  quality manual development  sop development  development of inspection documents  failure investigations  risk management iso 14971  cmdcas  21 cfr 1271 human cells, tissue, and cellular and tissue-based products  radioactive seeds for prostate cancer  complaint investigation  process validations  fmea development  fda investigation preparedness  fda 483 & warning letter remediation  design reviews  management reviews  quality management  microsoft office suite  statistical software