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Manage medical device software design and engineering processes from requirements all the way through to product validation. Take advantage of the medtech development knowledge built into this Medical Software Engineering Template to adopt best practices with minimal effort.

Use the template to ensure 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.

Ensure high product quality and accelerate regulatory audits using our Medical Audit & CAPA Management Template. Control quality documents, manage eForms and CAPA, and conduct Root Cause Analysis all in one place.

Adhere to regulatory requirements, simplify compliance assessments, and tackle compliance audits for QMS regulations including ISO 13485:2016 and FDA Title 21 CFR Part 820. Rely on this template to maintain rigorous quality control across the entire development lifecycle, to manage deviations from established processes, and to report on your quality activities in order to simplify audits.

The Pharma GAMP® 5 Template supports pharma companies, suppliers of production devices (automation technology and control systems), and system integrators in applying best practices in the management of computerized systems in a pharma environment.

Orchestrate your pharmaceutical validation processes with the Pharma GAMP® 5 Template, adhere to GAMP® guidelines, and maintain focus on product quality along the lifecycle. Rely on built-in documentation and best practices to achieve compliance with the Good Automated Manufacturing Practice® 5.

Support automotive embedded E/E and software development with Intland Retina! Use our ISO 26262:2018 & ASPICE Template to accelerate product innovation and delivery for digital mobility applications. The capabilities and domain knowledge baked into this template help simplify functional safety compliance and verification.