Main Purpose
The main purpose of Enzyme is to automate and simplify life science regulatory approval and compliance. It aims to reduce the cost of compliance and help bring cutting-edge technology in the life science industry to market faster.
Key Features
- Cloud-based Quality Management System (QMS): Enzyme offers a cloud-based QMS that streamlines documentation and integrates with existing tools used by life science companies.
- Regulatory and Compliance Lifecycle Support: Enzyme provides expert guidance throughout the entire regulatory and compliance lifecycle, including pre-submission, product design and development, regulatory submission, and post-market compliance.
- Focus on Digital Health and SaMD: Enzyme supports all life science companies, with a particular emphasis on those involved in digital health and software as a medical device (SaMD) products.
Use Case
- Life Science Companies: Enzyme is designed to support all life science companies, including those involved in digital health and SaMD products. It helps them navigate the complex regulatory landscape and streamline compliance processes.
