Core features that make it valuable
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Open Resource
Regulatory documentation and guidelines for free access and use in medical device compliance.
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Managed Services
Expert guidance on compliance strategy, technical documentation writing, and services for submissions.
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Web-Based Access
Customizable system to automate and streamline medical device regulatory compliance processes.
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Reg-Intelligence
Real-time regulatory intelligence and trends. Peer collaboration working group invitation.
Accessible Regulatory Expertise
Our regulatory intelligence and automation tools make advanced regulatory capabilities accessible to medical device companies, including small and medium-sized enterprises (SMEs) that traditionally lack regulatory expertise and resources.
By leveraging our tools, SMEs can achieve better regulatory efficiency and compliance at a fraction of the cost and effort of in-house expertise. Our solutions provide easy-to-use interfaces that automate tasks, generate submissions, securely manage data, and offer real-time regulatory updates. This allows even resource-constrained teams to rapidly develop compliant submission packages and enhance global competiveness.
Quick Deployment
Our regulatory automation tools can be quickly deployed, allowing MedTech manufacturers and consultants to rapidly integrate advanced capabilities without lengthy development and customization.
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Out-of-the-box solutions to streamline compliance
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Users can swiftly incorporate features like document generation and data management
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Accelerated deployment translates to faster device approval
Streamlined Efficiency for Compliance
As your business grows or compliance needs change, you can easily adjust the usage of our regulatory automation tools to match those needs. This flexibility ensures improved efficiency as an asset for medical device companies.
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80%
faster generation of technical files -
70%
reduced effort for data preparation and submission