Regulatory Filing
Successful companies will position themselves to jumpstart projects by leveraging structured business information based on customer feedback, supplier or internal best practices, while treating regulatory compliance as an asset in the development process, rather than an unwieldy requirement. Compliance and innovation must become complementary rather than conflicting processes.
Embedding Regulations as an Asset, not Overhead
Medical device companies struggle to keep up with the necessary and changing regulatory requirements. Both before the product is released, and after it is in use, many documents are required by the regulatory agencies to ensure safety to patients. Companies have tremendous efficiencies to gain if regulatory activities can be automated – a natural outcome of the process – and virtualized, minimizing the waste of both time and money on unnecessary resources.
Licensed to Cure for Medical Device solution allows companies to eliminate scattered processes and data and to “embed” regulations as an asset, optimizing quality and compliance and reducing cost and time to market.
Key Benefits:
- Complete workflow management, even for complex procedures and agencies interaction.
- Single Source of Truth: always up-to-date product & development process linked and available for regulatory submission team.IP can be identified, accessed and reused, saving time and money.
- “Bureaucratic” tasks to ensure procedural enforcement.
- Structured process and documentation such as “living” DHF and DMR bring full traceability and automated reporting and filing.
By leveraging the 3DEXPERIENCE platform that combines engineering, quality, and regulatory compliance business processes, we have moved closer towards becoming the R&D and manufacturing center of choice for our customer.
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