Smart tools for medical device compliance
The Compliance Navigator is a simple yet high-performance tool for managing the information required for medical devices. It helps streamline medical device compliance operations with a wealth of content and features, including regulations and related standards for medical devices in the UK, Europe, and the USA, as well as expert explanations, revision histories, and support documents for regulatory compliance. You can try out the actual features and content with a free trial. Please feel free to contact us.
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basic information
The Compliance Navigator contains over 4,000 documents essential for compliance with medical device regulations. With multi-user access, the entire team can use it simultaneously. - Notification of Standard Revisions Advance notice of upcoming standard changes allows the team to plan accordingly. - Individual Document Profiles for Devices You can create profiles of standards and regulatory documents for each product, allowing you to store all necessary information in one place, including links to related content outside of the Compliance Navigator. - Comprehensive Guides You can view relevant standards, rules, and regulations, helping to prevent missing important details. - Smart Support Documents and Expert Commentary By utilizing smart support documents for each topic, which include practical guides, you can prepare for MDR and IVDR. Additionally, expert commentary allows you to confirm the background and correct interpretation of new standards. - Revision History When key documents are revised, the changes are highlighted, making it easy to understand what has been updated.
Price information
*The annual subscription fee varies depending on the subscribed content and conditions. Please consult us for a separate estimate.*
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Applications/Examples of results
You are utilizing the notification feature to keep track of updates on regulations and standards. The explanations of the standards by experts are well-received as they are helpful for interpretation. Additionally, some customers are using the external document addition feature to centrally manage documents related to medical device regulatory compliance with the Compliance Navigator.
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Company information
BSI (British Standards Institution) is the world's oldest national standards body, providing services related to standards such as the development of new standards, the sale and subscription of standards documents, management system certification, product certification, and CE marking. Through the utilization of standards, we support businesses around the world in continuously achieving "excellence" and improving their performance.