In the highly-regulated world of medical device manufacturing, organisations have a duty to show that every device meets both customer expectations and applicable regulations. AVN Register (AVN) supports clients in their efforts to meet the stringent requirements of ISO 13485, fine-tuning product development lifecycles to ensure a timely market launch.The international quality management system (QMS) standard for medical devices, ISO 13485:2016 (Medical Devices – Quality management systems – Requirements for regulatory purposes) was published 1 March 2016, with the International Accreditation Forum (IAF) allowing certified organisations three years to transition from previous versions. ISO 13485:2012 maintains its status as the harmonised standard and the presumption of conformity until the end of the transition period.ISO 13485:2016 introduces a host of subtle, yet detailed, changes requiring more thorough documentation on the work environment, risk management, design control and regulatory requirements. The revised standard includes the need for a risk-based approach to the QMS, an enhanced focus on regulatory requirements and the responsibilities of top management, increased controls over suppliers and outsourced activities, and an emphasis on risk management throughout the product lifecycle.ISO 13485 applies to both manufacturers of medical devices and organisations that support medical device manufacturers. It underpins the manufacturers’ duty of ensuring devices consistently meet customer and applicable regulatory requirements.The updated ISO 13485:2016 replaces all previous versions in March 2019.
Need help with ISO 13485?
As the internationally recognised standard in the world of medical device manufacturing, ISO 13485 helps you beat the competition by minimising risks throughout your product development lifecycle.Thanks to AVN systematic approach, you will receive the appropriate support at every stage of product development facilitating a timely market launch.AVN provides a wide range of ISO 13485 services including certification, gap analysis and training, all of which are designed to support your journey towards successful compliance.