Jens Fröhlich
Principal Consultant Operations – Portfolio Management MEDTEC
Swissmedic is currently planning a nationwide inspection campaign among Swiss importers of medical devices. The background: Since the end of the MRA agreement with the EU, Switzerland has been considered a third country in the field of medical technology. Regulatory responsibility has thus shifted significantly – and now lies more with the companies that import products into Switzerland.
This new situation forces importers to critically examine their internal processes and structures. Who is responsible for which inspection? How is the documentation flow organized? And how is it ensured that compliance with documentation requirements is actually met? Unannounced inspections in particular may reveal that traditional processes are no longer sufficient. Those who have previously relied on manual inspections or fragmented system solutions face challenges that are difficult to manage in day-to-day business.
UDI, traceability and clear responsibilities
For example, unique product identification via UDI has long been mandatory, but it must not only be recorded correctly, but also managed digitally and be accessible at any time – ideally centrally and system-managed. Similarly complex is the traceability of serial and batch numbers or the proof that products have been introduced in compliance with applicable regulations (MDR, IvDR, Swissmedic). Added to this are requirements regarding test plans, document versioning, and role demarcation – for example, between the manufacturer, CH-REP, and importer.
ERP software in focus
These issues not only affect quality management or regulatory affairs, but also have a direct impact on the ERP system. This is where central information from purchasing, warehousing, production, service, and quality converge. If there is no clear system in place, uncertainty arises – especially when an inspection by the authorities occurs. Instead of addressing new requirements individually, an integrated approach is worthwhile.
KUMAVISION medtec365 in response
This is exactly why medtec365 developed: A solution specialized for medical technology based on Microsoft Dynamics 365 Business Central. The goal is not to introduce another isolated solution, but rather to embed regulatory requirements directly into company processes. This allows, for example, inspection and approval steps to be digitally controlled, complaints to be processed system-supported, and audit trails to be mapped in an audit-proof manner. UDI data, proof of conformity, and approvals are maintained centrally – traceable, transparent, and verifiable.
Keeping regulations under control, enabling scaling
Another advantage is scalability: The solution is cloud-based, can be flexibly expanded and integrates seamlessly with Microsoft applications such as Teams, Power Platform or Office 365This is less about an "IT implementation" but rather about the possibility of implementing regulatory requirements in a structured, transparent and efficient manner – while avoiding "subledger accounting", double entries or media disruptions.
Increased hand pressure
The pressure to act is increasing – and now is the right time to review. Swissmedic's increased controls are not an exception, but rather a glimpse into a new regulatory reality. Companies that review their processes and systems early on not only gain legal certainty but also operational stability. Those who examine early on how regulatory requirements can be supported systematically reduce risks – and are a decisive step ahead in case of doubt.
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