Tag: ISO 13485:2016


The Importance of Risk Management

Risk management is a key component to demonstrate regulatory compliance for medical devices, it contributes to the medical device company’s ability to meet the regulatory requirements for approval from local regulatory authorities. Effective risk management is essential for determining whether the benefits of the product outweigh any potential risk to the patient. ISO 14971 ’Medical devices – Application of risk management to medical devices’ is the international standard for the application of risk management by a manufacturer to medical devices, including in vitro diagnostics (IVD’s). ISO 14971 is accepted by the TGA......

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Tips for transitioning to ISO 13485:2016

Transition planning is critical As the March 2019 deadline for ISO 13485:2016 is fast approaching, now is the time to start actively planning for the transition. When planning for the transition, it is important to consider the resources and time required to update your Quality Management System (QMS) as well as regulator assessment times. In addition, companies must also define the project so that there is clear understanding of the specific processes that need the most work and the impact that this work has on any other requirements. Planning considerations We recommend......

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