Medical device’s global standard for quality management system gets a long-awaited amendment to a new standard: ISO 13485. However, the new amendment allows the manufacturers, regulators, certification bodies a time window of three years for the transition process. Till then the previous standards ISO 13485:2003 and ISO 13485:2016 will coexist. Through the revised standard, the International Organization for Standardization (ISO) intends to put more emphasis on the medical devices lifecycle, post-marketing surveillance guidelines, applicability and the entire supply chain. According to the release guidance, “any existing certification issued to ISO 13485:2003 will not be valid.”

Listed below are the major revisions that are defined in the new guidance:

  • In order to check the risk factors associated with the medical devices, companies are required to follow risk-oriented tactics to control the safety and performance measures of the devices
  • New guidelines for sterile barrier properties and manufacturing sites in terms of the infrastructure of sterile medical devices
  • Companies need to synchronize the software validation requirements associated with various applications such as process control software, quality control system, and monitoring & measurement software systems
  • Better harmonization of regulatory documents pertaining to regulatory requirements
  • Focus on management and reporting of compliance issues to the regulatory authorities as per the post-market surveillance and regulatory requirements
  • Documentation and management of corrective and preventive actions and corresponding implementation of corrective action at the earliest
  • Advanced emphasis on feedback mechanisms

Although manufacturers have three years by their side for meeting the updated requirements, it is essential to note that the new standard entails with whole medical device lifecycle – starting from design to development, manufacture, and distribution. This will consequently reflect the entire process and may pose a time challenge for medical device manufacturers. Therefore, it is crucial for companies to be familiar with the regulatory updates much in advance. In this context, an expert Medical Devices Regulatory Service provider can help companies to fast track the process of getting device approvals in new geographies as well as updating the existing ones according to the new standard.

ISO 13485:2016


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