Quality

Regulatory & Compliance

Quality, safety and traceability are at the core of every Thermova device. Our products are developed, manufactured and serviced under a documented quality-management system, with every unit individually serialised and recorded in our device history file.

Certifications & marks

  • CE marking — conformity with the applicable EU directives and regulations for the European Economic Area.
  • FDA Establishment Registration — registered manufacturer for distribution in the United States.
  • ISO 9001 — certified quality-management system.
  • ISO 13485 (in progress) — quality-management system specific to medical devices.
  • RoHS & REACH — compliance with EU substance-restriction frameworks.
  • WEEE — registered producer for electrical and electronic equipment take-back in Germany.

Manufacturing & quality control

Thermova devices are assembled in our Tuttlingen facility under documented work instructions. Every unit undergoes a 100% functional test, a thermal characterisation run and a final QA inspection before release. Test records are retained for the full lifetime of the device.

Cold-chain validation

Hold-time, recovery and stability data for each model are generated under controlled chamber conditions in accordance with the principles of IEC 60068 environmental testing. Validation reports are available to qualified buyers under NDA.

Battery safety & transport

Lithium-ion battery packs are certified to UN 38.3 and shipped in compliance with IATA PI 967 Section II and UN 3481 for air transport.

Vigilance & post-market surveillance

We operate a documented post-market surveillance and vigilance system. Report any device-related adverse event, malfunction or near-miss to vigilance@thermova.com. Reports are acknowledged within one business day and investigated under our CAPA (Corrective and Preventive Action) procedure.

Documentation on request

Distributors, hospital procurement teams and regulatory authorities may request the following from quality@thermova.com: CE Declaration of Conformity, FDA registration number, ISO certificates, Material Safety Data Sheets, battery test summaries and validation reports.