FDA Quality System Compliance

• 21.CFR.820
  • This quality system is known as Medical Device Good Manufacturing Practices and provides the framework for ensuring that medical devices are being manufactured according to state-of-the-art manufacturing standards for that specific device.
  • Learn more about 21.CFR.820
• Corrective and Preventative Action (CAPA) programs
  • We are able to implement or improve existing CAPA programs on behalf of your company to effectively identify correct product and quality problems. CAPA programs are also used to prevent prevent the reoccurrence of any identified issues and is an important quality system element.
  • Learn more about CAPA programs.

International Quality System Compliance

• ISO 13485 Implementation
  • ISO 13485 standards were developed to ensure safety and quality for medical devices. Our team has experience in using ISO 13485 to set up quality systems and ensure top-level compliance for medical devices.
  • Learn more about the ISO 13485 standards.
• Medical Device Single Audit Program (MDSAP)
  • MDSAP is a global approach to auditing and monitoring the manufacturing of medical devices. International members include Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency, and U.S. Food and Drug Administration
  • Learn more about MDSAP