Trusted by the world’s leading healthcare & medical device companies

Reliability, safety, security and quality-control factors drive the success, and contribute to the reputation of companies in this segment. With their landscapes further complicated by evolving regulations and compliance, these organizations rely on proven technologies to develop their products and services.

Modern Requirements4TFS is used by leading healthcare and medical device organizations all over the globe

Collaborate

The review, discussion and approval functions in Modern Requirements4TFS help diverse groups of business, client, and IT stakeholders worldwide. Specifically, the functions enable these groups to collaborate to drive consensus and resolution, as they innovate on various initiatives. Each review workflow is governed by a set of rules, so that managers can adjust based on the type and size of project at hand. Discussions, comments and approvals are saved in the database, so the organization can always reference why important decisions were made.

Achieve, maintain, and prove compliance

Organizations in this industry are governed by FDA and HIPPA regulations to document their requirements management process with complete traceability while meeting standards such as: ISO 14971 (Risk Management), ISO 13485 (Quality Management) and 21 CFR Part 11 (Controls and Audit trails).
Specific capabilities to support include: end-to-end traceability, managing the impact of change, verification and validation design, reviews and approvals with e-signatures and risk analysis – all built into Modern Requirements4TFS.

Make better decisions

Modern Requirements4TFS provides visibility for Agile and traditional requirements in one central source of truth, with traceability. As a result, you can share information easily within your organization and with external stakeholders and clients. Management analytics and reporting capabilities provide you with valuable insight to guide direction and adjust as needed.

Reduce costs and increase speed to compete

With Modern Requirements4TFS, your organization will benefit from fewer defects, less rework and improved time to market through the process of automation provided. Business and IT stakeholders alike share an understanding of requirements, helping both align with their corporate objectives.

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