Aligning QMS and Engineering Processes in Medical Product Development

Aligning Quality Management Systems and Software Engineering Processes in Medical Device 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 standards and regulations like FDA 21CFR820, EU Medical Device Regulations, IEC/ISO 62304, IEC 82304, and ISO 14971 is one of the critical calls for MedTech companies. They need to demonstrate how their quality and regulatory goals implemented in practice.

In an increasingly Agile environment, providing this level of traceability across documents, requirements, product risk management artifacts, and software development lifecycle processes is particularly challenging with the current set of tools.

In this presentation, Intland Software’s expert will discuss the key challenges and solution on how to align Quality Management Systems and Application Lifecycle Management (ALM) processes in the medical software domain. The talk will cover the use of advanced development lifecycle management capabilities of the ALM tool to integrate quality and regulatory contents with software engineering, software development, and software quality assurance activities.

Was lernen die Zuhörer in dem Vortrag?

Join this talk to learn how to integrate document control into the software engineering documentation lifecycle, how to manage approvals (with e-signatures), and how to achieve alignment between Quality Assurance and Software Engineering teams.
Understand how Intland's concept helps achieve traceability across documents and regulatory submission contents down to all artifacts created during the product development.

Szabolcs Agai
Szabolcs Agai

Mr Agai has over 25 years of experience in the field of quality, regulatory and functional safety for the medical, the automotive, the railway and the...

45 Minuten Vortrag

Fortgeschritten
Zeit

11:45-12:30
23. Oktober


Raum

Raum "Brüssel"


Schwerpunkt

Qualitätsmanagement in der Medizintechnik


Zielpublikum

Everyone dealing with quality management and developing healthcare products


ID

Mi5.2

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