![\"\"](\"https:\/\/medtech-ingenieur.de\/wp-content\/uploads\/2025\/09\/39.png\" "\\"39\\"")
<\/span><\/p>\nGoran Madzar<\/h4>\n
Systems Engineer & CEO @MEdtech Engineer<\/p>\n
Why FPGAs are becoming regulatoryly relevant in medical technology<\/h2>\n
FPGAs, CPLDs and other programmable logic devices are specifically used in modern medical products where high performance, deterministic real-time behavior and complex logical decisions are required.<\/p>\n
Typical reasons for the use of FPGAs\/PLDs in medical technology include:<\/p>\n
- \n
- High performance and low latency\n
- \n
- true parallel processing<\/li>\n
- deterministic real-time behavior<\/li>\n<\/ul>\n<\/li>\n
- complex logical decisions\n
- \n
- State Machines<\/li>\n
- Monitoring and plausibility logic<\/li>\n<\/ul>\n<\/li>\n
- Time-critical signal processing\n
- \n
- Filter, trigger, encoding\/decoding<\/li>\n<\/ul>\n<\/li>\n
- architectural separation\n
- \n
- independent safety layer<\/li>\n
- Firmware monitoring<\/li>\n<\/ul>\n<\/li>\n
- determinism\n
- \n
- no scheduling<\/li>\n
- no interrupt cascades<\/li>\n
- no operating system<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n
These very characteristics make FPGAs attractive for safety-critical functions \u2013 and this is the real reason why they are attracting regulatory attention. IEC 62304, FDA guidance, and notified bodies focus less on the technology used and more on the systematic function that an element performs within the overall system. The focus is not on how something is implemented, but on what it does. And as soon as this function is "software-like," IEC 62304 inevitably comes into play.<\/p>\n
FPGA and IEC 62304: Engineer's View vs. Auditor's View<\/h2>\n
From a development perspective, the situation is usually clear:<\/p>\n
- \n
- The FPGA is programmed only once.<\/li>\n
- It is not reconfigurable in the field<\/li>\n
- It behaves deterministically, like hard-wired logic.<\/li>\n
- VHDL\/Verilog describes structure, not process control<\/li>\n
- There is no processor, no instructions, no operating system.<\/li>\n<\/ul>\n
All these points are technically correct and important. However, the regulatory perspective focuses on something else. It doesn't ask about the programming language, but rather about responsibility within the system.<\/p>\n
- \n
- Does the FPGA make decisions?<\/li>\n
- Is he evaluating states or limits?<\/li>\n
- Does it trigger any security-related actions?<\/li>\n<\/ul>\n
If the answer \u201e"Yes"\u201c<\/strong> The FPGA inevitably ends up in the software discussion, regardless of whether it is described with C code or HDL.<\/p>\n
When an FPGA is considered software<\/h2>\n
In practice, critical discussion usually arises when the FPGA:<\/p>\n
- \n
- Safety-relevant limit values are monitored.<\/li>\n
- Conditions assessed or classified<\/li>\n
- triggers shutdowns or emergency stop signals<\/li>\n
- independent of the firmware, decisions are made<\/li>\n<\/ul>\n
The fact that the FPGA is programmed in VHDL and not in C is irrelevant. The more safety-relevant logic is moved to the FPGA, the more auditors and authorities expect a structured, traceable development and documentation strategy.<\/p>\n
Practical application: IEC 62304 documentation for FPGA projects<\/h2>\n
Several clear lessons can be drawn for practical application:<\/p>\n
- \n
- The FPGA should be integrated into the project early on.<\/li>\n
- Architectural decisions must be clearly documented.<\/li>\n
- The risk argumentation must not be a retrospective \u201eaudit fix\u201c.<\/li>\n
- Standards should be used as tools, not as straitjackets.<\/li>\n<\/ul>\n
Taking these points into account significantly reduces the documentation effort and avoids unpleasant surprises during the audit or shortly before approval.<\/p>\n
FPGA gap analysis for regulatory safety<\/h2>\n
When an FPGA takes on safety-relevant functions, the question quickly arises as to how it can be meaningfully and audit-proof integrated into the IEC 62304 documentation \u2013 without unnecessary overhead, but with regulatory certainty.<\/p>\n
A proven first step is an IEC 62304 gap analysis to:<\/p>\n
- \n
- to clearly define the role of the FPGA in the system<\/li>\n
- To evaluate relevant standard requirements in a structured manner<\/li>\n
- Identifying documentation gaps early<\/li>\n
- to realistically estimate the actual effort required<\/li>\n<\/ul>\n
You can find more information on this topic on our IEC-62304 Gap Analysis page:<\/p>","protected":false},"excerpt":{"rendered":"
Warum FPGAs in Medizinprodukten zunehmend in den Fokus von Software-Audits geraten und wie Sie regulatorische Risiken fr\u00fchzeitig vermeiden. Wenn programmierbare Logik pl\u00f6tzlich im Software-Audit landet, kann es schnell ungem\u00fctlich werden, wenn der Auditor Sie fragt: \u201eWo ist Ihre IEC-62304-Dokumentation f\u00fcr den FPGA?\u201c Diesen Satz h\u00f6ren MedTech-Teams immer h\u00e4ufiger und oftmals \u00fcberraschend sp\u00e4t im Projekt oder […]<\/p>\n","protected":false},"author":1,"featured_media":13378,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","tve_updated_post":"
Warum FPGAs in Medizinprodukten zunehmend in den Fokus von Software-Audits geraten und wie Sie regulatorische Risiken fr\u00fchzeitig vermeiden.<\/h1>
Wenn programmierbare Logik pl\u00f6tzlich im Software-Audit landet, kann es schnell ungem\u00fctlich werden, wenn der Auditor Sie fragt: \u201eWo ist Ihre IEC-62304-Dokumentation f\u00fcr den FPGA?\u201c<\/p>
Diesen Satz h\u00f6ren MedTech-Teams immer h\u00e4ufiger und oftmals \u00fcberraschend sp\u00e4t im Projekt oder sogar erst im Audit. Die erste Reaktion ist dann meist:<\/p>
\u201eDas ist doch Hardware.\u201c
\u201eDa l\u00e4uft kein Code.\u201c
\u201eDer FPGA ist nicht updatef\u00e4hig.\u201c<\/p>Und technisch betrachtet ist das v\u00f6llig richtig. Dennoch entsteht genau an dieser Stelle regelm\u00e4\u00dfig z\u00e4he Diskussionen in Medizintechnik-Projekten: Ist ein FPGA Software oder nicht?<\/p><\/div>
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