Quality Systems Services        

• Performing Quality System Gap Assessments (FDA QSR, EU MDR, JPAL, ISO 13485 and under the MDSAP Program)
• Development and implementation of a sustainable Quality System (FDA QSR; EU MDR, 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,
    DEKRA, SGS, TÜV SÜD and TÜV Rheinland.