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Many medical device companies must
meet the requirements of the FDA's QSR and the European CE Mark (MDD,
IVD, AIMD). Peak has assisted companies meet these regulations by
performing gap audits, conducting training, facilitating
implementation and assisting with technical files. We at Peak
believe that a company can create a single documented Quality
System that is versatile enough to meet all the requirements of
any market. Clients include Varian Associates in Palo Alto, Cygnus
and Perclose in Redwood City, Orquest and Aerogen in Mountain View
and Becton Dickinson in San Jose. Peak has presentations, workshop
materials, checklists, regulation comparisons, and many guidance
documents to support these activities. |
