Aligning QMS and Engineering Processes in Medical Product Development
Regulatory pressure is prompting developers of digital healthcare products to adjust their approach to quality. As regulators are extending scrutiny from development processes to overall organizational excellence, companies are forced to adopt robust Quality Management Systems.
Compliance with the guidelines of standards like ISO 13485 and FDA Title 21 CFR Part 820 require medtech developers to show evidence of how their development processes align with quality documents. They need to demonstrate how their quality goals are implemented in practice. In an increasingly Agile setting, providing this level of traceability across documents, requirements, and development lifecycle processes is notoriously difficult to achieve using currently available tools.
In this talk, Intland Software’s expert will present a solution to aligning QMS and ALM (development) processes. The talk will cover the use of advanced document lifecycle management capabilities to integrate quality documents with engineering, development, and QA activities.
Was lernen die Zuhörer in dem Vortrag?
Join this talk to learn how to integrate document control into the engineering documentation lifecycle, manage approvals (with e-signatures), and achieve alignment between Quality Assurance and engineering teams. Understand how Intland's concept helps achieve traceability across documents and regulatory work items down to all artifacts created during product development.
Qualitätsmanagement in der Medizintechnik
Everyone dealing with quality management and developing healthcare products