Why functionality is not enough
In the medical and funeral sectors, every device must meet strict requirements for design, manufacturing, and documentation.
How does MedDom achieve this? Find out in the article.
What ISO 13485:2016 certification means
It is the international standard for quality management systems applied to medical devices.
Requirements for certified companies
Those holding the certification — like MedDom — must ensure:
- documented quality controls at every production stage;
- traceable materials and healthcare-compliant processes;
- full product lifecycle management;
- periodic audits by independent third-party bodies.
MedDom: certified quality, Made in Italy
MedDom manufactures mortuary refrigeration units and refrigerated cabinets compliant with ISO 13485, officially registered as medical devices with the Italian Ministry of Health.
Choosing MedDom means choosing:
- regulatory certainty
- traceable quality
- the reliability of Made in Italy, backed by a fully integrated supply chain.
