GMP and CE Certification Case Study

Regulatory-Affairs-Support
CHALLENGE:

Major pharma company purchased a medical device business, seeking to achieve CE certification and remain compliant under GMP regulations


APPROACH:

An experienced AlvaMed team developed a project plan consistent with ISO 13485 and the MDD

  • Performed a gap analysis
  • Developed a project plan
  • Provided training
  • Project managed a multi-site international implementation
  • Influenced strategy for appropriate annex path certification


RESULTS:

Risk analyses and 510(k) draft completed on time; AlvaMed training and templates gave client confidence to perform future risk analyses themselves