ISO 13485 Regulations

Achieve ISO 13485 Certification

ISO 13485 is a Quality Management System standard designed for medical device companies. Being ISO 13485 compliant shows a commitment to the safety and quality of your medical devices. Documented compliance to an ISO Standard, even in the absence of certification, speaks volumes about how you run your company and the kind of partner you will be. For globalizing your medical device outside the United States, ISO 13485 certification is almost always required.

Our medical device consultants will help prepare your business operations and documentation to establish your compliance with ISO standards and enable you to demonstrate your commitment to product safety, quality and reliability. If you are currently compliant with FDA regulation 21 CFR Part 820, MethodSense will ensure a smooth and efficient compliance path by fully leveraging your current Quality Management System.

ISO 13485 Certification Solutions

Our solutions allow you to confidently manage your quality, manufacturing, business processes and much more, with document control, record retention and audit trails. We support ISO 13485 certification with our proprietary pre-validated software solutions, LuminLogic Smart Enterprise Suite and LuminLogic Smart Solutions. This tool, combined with our medical device regulatory expertise, enables you to:

  • Understand the requirements for ISO 13486 certification
  • Establish a risk based approach to product development and realization
  • Complete the validation of processes
  • Ensure compliance with regulatory requirements
  • Implement effective product traceability and recall systems

Using LuminLogic Smart Enterprise Solutions, our regulatory document management tool, your materials will be organized in a way that makes it easy to demonstrate the safety and effectiveness of your device and risk management processes. Click here to learn more about LuminLogic’s regulatory document management software capabilities.

Our goal is to help you achieve easier compliance, more efficient validation and improved process management.

To Ensure Your Device Gets To Market Quickly And Without Unnecessary Delay, Schedule An Appointment With One Of Our Regulatory Affairs Consultants Today

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