(Estimated reading time: 2 - 3 minutes)
Wolfgang Renner

Wolfgang Renner

Heads the health market and medical technology department of KUMAVISION and is also responsible for quality management in this function

Why it is so important for medical technology to move from traditional methods to modern software validation

The validation of computer systems is an important part of an effective and certified quality management system, particularly through the MDR and EN ISO 13485. In the medical technology industry, there are two key terms that everyone should know: CSV (Computer Systems Validation) and CSA (Computer Systems Assurance). The main aim of CSV is that basically all processes in the system must be validated.

A weak point of the classic CSV is primarily the creation of extensive documentation as an end in itself, without checking the necessity of the scope of documentation and without added value for patient safety or product quality. CSA, on the other hand, is a more modern, risk-based approach to validating computer systems. The method places a strong focus on critical thinking, automation and inclusion Cloud-Providers or suppliers.

blog csa csv infographic

The problem: Many medical technology companies still stick to CSV. I asked myself: Why? And why should they urgently switch to CSA? But the crucial question is: What does KUMAVISION medtec do?365 so revolutionary in this context?

Tradition vs. progress

CSV has been established as the standard in medical technology for decades. This is because it offers companies a secure foundation: a system that has proven its reliability and compliance time and time again. But this apparent advantage can also be a hindrance. The constant need for re-validation after every system change (or change request) can slow down innovation and limit flexibility.

medtec365: A lighthouse of modernity

With medtec365 KUMAVISION has taken a decisive step into the future. The on Microsoft Dynamics 365 based platform relies on CSA and relieves customers of the often seemingly rigid CSV processes. CSA in conjunction with medtec365 is more than just a software solution. It stands for agility, risk-based security and compliance. It ensures that medical technology companies can react quickly to market changes.

Conclusion: A new era of industry software for medical technology manufacturers and dealers

In a constantly changing medical technology industry, we at KUMAVISION are proud to be actively involved in this change. It is encouraging to see how technology and innovation work hand in hand to drive the industry forward. I am convinced that we will take the next big step with the industry software together with our customers and partners. It's an exciting time and I can't wait to experience and shape it together with our customers.

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