HeroSupport

HeroSupport specialises in adjustable table shells designed to enhance patient support during medical imaging and treatment procedures. Their primary product, the VENUS SHELL, integrates with existing medical tables to provide customisable, patient-specific positioning. This reduces the need for manual adjustments and improves comfort and precision in settings like radiology, interventional radiology, and surgery.

HeroSupport is based in Switzerland, which is part of the European Union regulatory space. Since their devices are intended for use within the EU, they comply with EU medical device regulations, including classification under the applicable EU Medical Device Regulation (MDR) or Medical Device Directive (MDD). This ensures their products meet the necessary safety, performance, and compliance standards for the European market.

HeroSupport’s VENUS SHELL is classified as a Class I medical device under EU regulations. This classification is determined by its intended purpose—providing adjustable support for patients during medical procedures—and its risk profile, which is deemed low enough to qualify for this category. Class I devices typically require compliance with general safety and performance requirements but may not always need pre-market clinical evaluations, depending on specific regulatory pathways.

Yes, HeroSupport’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. Listing in EUDAMED is mandatory for manufacturers to demonstrate compliance with EU regulatory requirements and to provide transparency on their products’ market status, classification, and regulatory history. This helps healthcare professionals, authorities, and other stakeholders verify key details about the device’s authorisation and compliance status.