Developing medical technology products? Use this template to manage your medical device software design and engineering processes for compliance with EU MDR and US FDA regulations and applicable standards: IEC 82304-1, IEC 62304, ISO 14971, and FDA 21 CFR Parts 11 & 820.
Take advantage of built-in MedTech development knowledge to adopt best practices with minimal effort. This template covers the development lifecycle of MedTech software from requirements all the way through to validation.
MedTech developers can use this template to ensure high-quality products, accelerate regulatory audits, control quality documents, manage forms and CAPA, and conduct root cause analysis all in one place:
The Good Automated Manufacturing Practice® 5 (GAMP® 5) Template supports pharma project validation and quality risk management, ensuring high-quality products, minimum waste, and regulatory compliance.
Pharma companies, production device suppliers (automation technology and control systems), and system integrators all rely on GAMP® 5’s built-in documentation for applying computerized systems management best practices in the pharma environment to achieve compliance.
For automotive embedded systems developers, this template helps minimize the use of resources, cut audit preparation costs, and tackle regulatory compliance (ISO 26262:2018, ASPICE, CMMI, and other regulations).
The template comes with baked-in domain knowledge, automotive best practices, and compliant workflows right out of the box. Adjust built-in processes and reduce the time it takes for teams to define mature automotive systems engineering and development processes.
This Airborne Electronic Hardware Template comes preconfigured with aviation domain knowledge, predefined work items and processes, and best practices to support product delivery in accordance with aviation regulations:
This ISO 9001:2015 QMS Template helps reduce time, effort, and costs of building and maintaining a thorough quality management system (QMS):
This Requirements Management Template is designed to help collaboratively specify, manage, and trace software requirement coverage:
Improve product quality and build real confidence in your products. This Test Management Template is preconfigured to support a comprehensive set of software testing activities. It comes with predefined artifacts for test configuration, test cases, test sets, and test runs.
Ensure meticulous testing and traceability across QA process. Provide your teams with a collaborative platform for managing testing activities and tracing them back to product specifications.
This Scrum Template has been created to support teams working with the Agile framework using scrum or kanban. Manage and monitor Agile development and provide your teams with a powerful collaborative platform.
This template provides a great basis for any Agile project. Support your teams with preconfigured work items, advanced release and sprint management capabilities, and domain knowledge built into a collaborative workspace.
Provide your team members with a transparent way to manage, edit, and share documents. Simplify documents publishing using configurable workflows. Ensure change control over all your documents.
This Document Management Template helps your teams handle all documents in a transparent, organized, and efficient way. The template comes preconfigured with a public documents artifact type to help make documents available to all members of your organization.
Looking to implement the Scaled Agile Framework (SAFe®)? This template is used by enterprises for a safe and smooth transition to Agile:·
The Agile-Waterfall Hybrid Template helps to combine Waterfall/V-model, Agile, scaled Agile, and custom development processes in complex, multitier systems development. Maintain structure and integrity while giving teams more freedom: