MEDXD - Online Sessions
On September 26 & 27, 2023, MEDXD - Medtech meets Digital will take place in Berlin - THE EVENT for the digitalization of product lifecycle incl. manufacturing processes in the IVD & medical technology industry.
As an extension of the event, we offer the two interactive sessions "A - Digital Regulatory Compliance" and "F - Software Tool Validation (CSV/CSA)" as hybrid session.
Let's go digital!
The IVD & medical medical industry is one of the most innovative in the world, but continuously increasing regulatory requirements are slowing down innovation. Digitalization of product lifecycle processes is progressing slowly in the industry: most processes are still documented "manually" using Word, Excel, PDF or even paper printouts.
However, regulatory changes in Europe are forcing industry stakeholders to reorganize. This costs energy, time and money. And massively slows down the development of new products and medical innovations. This, in turn, affects patient care and, ultimately, each and every one of us.
Therefore it's time to act! The regulatory challenges are an opportunity to question old-fashioned processes and to achieve an efficiency that is impossible with Word and Excel by using digital solutions.
With the MEDXD, we have launched a dialog event in 2022 on topics related to the digitalization of product lifecycle processes in the IVD & medical device industry. More information can be found on the official website: medtechX.digital
Online - Interactive Sessions
Interactive Session A: Digital compliance with regulatory requirements
Professionals in regulated industries know the importance of standards and demonstration of regulatory compliance. For a long time, standards have been provided as printed paper version or PDF files. Content was manually extracted and integrated into product development activities such as requirements engineering and test management. But the well known process for standard content creation, management, delivery and usage will change dramatically from 2024 on, enabling the full use of the potential of digitalization and efficient data integration.
SMART Standards: Concept, benefits & current status
Digital services provided for standards for an efficient management of regulatory information
Digital thread for regulatory information: Interface to Nautos Database & integration into product development
Case Study: Why and how Miltenyi Biotec digitalizes regulatory information
Q&A session & discussion
Interactive Session F: Computer System Validation & Assurance (CSV/CSA) for PLM/ALM Software
Digitalization requires the use of different software applications, which in many cases are intended to digitalize different processes, either alone or in combination. Regulatory requirements define: a software application must be validated for the defined intended purpose before the initial use and after changes. That means: Every software implementation also requires validation. But what is best practice with a balanced effort vs. benefit approach, in particular for quality management system software, such as PLM/ALM tools?
Which activities are necessary for validation of process software to achieve compliance with EU & MDSAP requirements?
Is GAMP5 really the best practice for validation of QMS software in the medtech industry?
How can the validation effort be brought to a reasonable level with a risk-based approach?
Why it is mandatory to rethink your validation approach: The new FDA's CSA guidance and it's impact in the EU
Q&A & Discussion: Application of the risk-based approach for different software applications
Presenters
Tickets & Registration
Are there any questions? I am here for you.
iris.mannhart@avasis.biz
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