Standards & Certifications Applicable to Medical Device & Pharma Sector

 

    1: EXCIPACT Certification

    2: EFfCI Certfication

    3: ISO 13485:2015 Quality Management Systems for Medical Devices

    4: GMP Pharma for Good Manufacturing Practices

    5: GDP - Good Distribution Practices

    6: ISO 135378:2017 - Packaging for Medical Devices

    7: CE - Medical Devices including 

    8: Invitro Diagnostic Medical device Regulation (EU) 2017/746 (IVDR)