Training and consulting in QMS, Validation, Risk Management, FMEA, Statistical Methods, SPC for Medical Device, Aerospace, and Manufacturing Organizations.

With over 20 years of experience in regulated medical device and aerospace environments, Apex Quality Consulting helps organizations implement effective quality systems, prepare for audits, validate manufacturing processes, manage risk, and maintain regulatory compliance.

Areas of expertise include:

• ISO 9001, ISO 13485, AS 9100

• MDSAP

• FDA compliance

• Validation

• Risk management

• Supplier quality

• Design Transfer