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Medical Device Regulatory ConsultantsISO Certification for Medical Device Companies

A company is ISO compliant when it demonstrates that it follows International Organization for Standardization (ISO) guidelines. Global commercialization of your medical device most often requires ISO 13485 Certification. Also, a deep understanding of ISO Standards, such as ISO 14971, is critical to establishing the safety of your product per IEC 60601-1 3rd Edition. Moreover, 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.

Our medical device consultants will help prepare your business operations and documentation to establish your compliance with ISO standards and enable you do demonstrate your commitment to product safety, quality and reliability.

Important ISO standards for medical device companies include:

ISO 13485: design and manufacture of medical devices

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. Our medical device experts will help you:

  • 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

ISO 14971: medical device risk management

ISO 14971 specifies a process for medical device manufacturers to identify the hazards, or risks, that are associated with their products and to create the necessary controls to monitor them. Our medical device consultants work with you to:

  • Assess the essential performance of your medical device
  • Identify potential hazards
  • Estimate the severity and likelihood of the hazards
  • Create controls to minimize the risks

ISO 9001: quality management for medical device manufacturing

ISO 9001 specifies the requirements for a quality management system for companies that need to demonstrate their ability to provide a product that meets both customer and regulatory requirements. Our quality professionals help medical device companies become ISO 9001 compliant by helping:

  • Implement a Quality Management System
  • Create standard operating procedures
  • Conduct QMS audits
  • Deliver consistent services based on a QMS

Speak to a MethodSense consultant about helping your medical device company become ISO compliant.