Medical Devices Quality systems are all about management providing the rigor and discipline to drive product quality to meet customers' needs and providing the information that is the life blood of management effectiveness.

In medical device industry, ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management system. Adopting ISO 13485 provides a strong foundation for manufacturers to address the global Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and effectiveness of medical devices.

ISO 13485 is the best globally accepted model a medical device organization can implement to help demonstrate compliance to regulations and laws of the medical device industry. ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world, including the TGA, FDA, Health Canada and other high regulatory bodies.

Quality Systems Services:

A well-executed quality system drives excellence, bringing your business processes under control and giving you the information you need to drive continuous improvement. Your employees and partners will understand their role in the Quality System and the value they add to it through compliance.

  • DHF, RMF, Tech File Remediation
  • Implementation or upgrade of systems to compliance with ISO 13485 2016 and FDA 21 CFR 820
  • Outline how to review and improve processes across your organization
  • Process development and implementation for distributors including
  • Post market systems for adverse event reporting
  • Remediation for non-conformities after FDA 483 / warning letters
  • Compliance to ISO 14971, ISO 62304, IEC 60601 4th Edition.

SARACA Benefits:

SARACA will own partially or fully the quality management responsibilities to ensure you achieve your quality goals and objectives. ISO 13485 provide direction to medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.

  • Effective CAPA Management
  • Additional Revenue with increase access to more markets worldwide with certification
  • Assistance with facility inspections including internal pre-audit and attendance at external audit
  • Increase efficiency, cut costs and monitor supply chain performance
  • Demonstrate that you produce safer and more effective medical devices
  • Assistance with facility inspections including internal pre-audit and attendance at external audit.

When you are selling your products both US and OUS, you will need to meet requirements in multiple markets. You can build one Quality System that is compliant to both ISO 13485 and the US FDA 21CFR 820 Quality System Regulations. We can advise you on more specialist GxP requirements, including ISO14971 and specialist quality systems for clinical laboratories and for R&D facilities or design houses.