Pall Medical products are manufactured in accordance with Title 21 of the Code of Federal Regulations.  Part 820 - Good Manufacturing Practices (United States) and applicable Pall Corporation specifications. Our Quality Management System has been approved by Lloyd's Register Quality Assurance limited to the following standards:

• ISO 13485:2003 
• ISO 9001: 2000
• Medical Device Directive 93/42/EEC and Medical Device Regulation 2002:618
• In Vitro Diagnostics Directive 98/79/EC
• Canadian Medical Device Regulations P.C. 1998-783, May 7, 1998
• Food and Drug Administration Title 21 Code of Federal Regulations   
    Part 820:  Quality System Regulations (QSR) as amended   
    Part 210: cGMP in Manufacturing, Processing, Packing or Holding of Drugs; General 
    Part 211: cGMP for Finished Pharmaceuticals.
• Japanese Pharmaceutical Affairs Law as per:
  - MoHLW Ministerial Ordinance No.169, 2004, Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents
  - MoHLW Ministerial Ordinance No.2, 1961 and subsequent amendments, Regulations for Buildings and Facilities for Pharmacies, etc.
  - The Pharmaceutical Affairs Law Enforcement Ordinances, 2005
          - Article 35, Application of Authorization for Foreign Manufacturer
          - Article 36, Authorization Categories of Overseas Manufacturer