Regemon LLC
  Regulatory Affairs and Quality Systems Consulting
Quality Systems

Quality Systems Services

§         Performing Quality System Gap Assessments (FDA QSR, MDD, EU MDR, JPAL, CMDCAS, ISO 13485)

§         Development and implementation of a sustainable Quality System (FDA QSR; EU MDR, CMDCAS and  ISO 13485)

§         Conducting Due Diligence audits

§         Corrective Action System

§         Internal and external (supplier) audits

§         Conducting Mock FDA Inspections

§         Customized In-house Quality System Training

§         Assist in choosing the right Notified Body1


1) Regemon consultants have extensive experience with the following Notified Bodies: BSI, NSAI, SGS, TÜV Essen, TÜV Product Services and TÜV Rheinland. 

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