In this post, we’ll explore how Jama Connect for Medical Device Development is designed to help you get ramped up quickly with a platform, training, and documentation aligned to industry regulations ISO 13485:2016, 21 CFR 820.30, and ISO 14971:2019, while applying a proven systems engineering approach to product development.
With this solution, medical device teams can manage design controls for device requirements and related risks, simplifying regulatory submissions and audit preparations while accelerating time to market.
Manage Design Controls for Device Requirements and Related Risks in a Single Platform
Easily Demonstrate Traceability
Traceability ensures that design inputs have been met and verified, providing necessary evidence from the design control process. Jama Connect allows you to easily produce traceability documentation required by regulators.
Manage Risk Analysis
Manage risk analysis, aligned with ISO 14971:2019. Jama Connect helps teams identify and mitigate risks earlier in medical device development, saving teams from frustrating late-stage design changes and supporting the path to regulatory compliance.
Maintain Audit Trails and Export Data
Real-time reporting and baselining allows you to track all changes to information within the system, including timestamps and associated users. Data is easily exported from Jama Connect if your current process dictates storage of documentation in a quality management system (QMS).
Reuse and Baseline Management
Compare versions of a requirement, generate branches to develop a variant, and create catalogs of reusable requirements to improve medical device development.
Compliant Reviews and Approvals
Increase early stakeholder visibility and participation in the review process with electronic signatures that are compliant with FDA 21 CFR Part 11.
Design Verification and Validation
Seamlessly manage traceability to verifications and validations, providing evidence to comply with government regulations and standards, like 21 CFR Part 820.30.
Flexible, Scalable Options with Jama Connect for Medical Device Development
Jama Connect for Medical Device Development Solution’s license model is fully scalable, ensuring rapid deployment and easy adoption of the solution across your product development team. It also allows flexibility and can be customized to your team’s unique needs. Download this datasheet to learn more about key product benefits and features, unique licensing types, and templates templates provided as part of the solution.
To see more information specific to the medical device development industry, we’ve compiled a handy list of valuable resources for you!