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The new article provides an overview of the new guidance document dedicated to the processes and procedures associated with the review of certain regulatory decisions.
Canada
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices. Table of Contents Health Canada, the Canadian healthcare product regulatory authority, has released a draft guidance on determining medical device...
Asia
This article highlights key medical device regulations to know in 2023 and their implications for the industry. Table of Contents In the ever-evolving landscape of healthcare, medical device regulations play a vital role in ensuring the safety, efficacy, and...
Canada
This article highlights he current regulations for medical devices in Canada, the process of registering compliant devices, potential changes being considered, and the potential impact on stakeholders. Table of Contents The use of medical devices is essential in...
Medical Devices
This article highlights he differences between intended use and indications of use, along with their significance. Table of Contents In the highly regulated world of medical devices, precision in terminology makes a significant impact. It is important for preparing...
ISO Standards
This article highlights details of ISO 14971 and its significance in ensuring the safety and quality of medical devices. Table of Contents In the field of medical device development and manufacturing, ensuring the safety and effectiveness of products is of paramount...
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