VIVA BEAUTY GROUP — Compliance
Certifications That Actually Mean Something
Every machine we build is designed to meet international medical device and laser safety standards. We don’t just put logos on a brochure — we maintain active certifications, undergo regular audits, and provide full documentation for your local regulatory requirements.
Active Certifications
Each certification covers our full product line. Documentation is available on request — we send you the actual certificates, not summaries.
CE Marking — Medical Device Directive
The CE Mark under the Medical Device Directive (93/42/EEC) is your gateway to the European Union, EEA, and many other markets that recognize CE certification. Our machines are tested by an EU-accredited Notified Body and comply with all essential requirements for medical electrical equipment.
FDA 510(k) Clearance — United States
FDA 510(k) premarket notification demonstrates that our device is substantially equivalent to a legally marketed predicate device. This clearance is required for legal sale and clinical use in the United States. Our submission includes comprehensive electrical safety, laser output, and biocompatibility testing data.
ISO 13485:2016 — Medical Device Quality Management
ISO 13485 is the global gold standard for medical device quality management systems. It covers everything: design control, supplier management, production process validation, traceability, complaint handling, and corrective action. Annual surveillance audits by an accredited certification body keep us honest — and keep our processes improving.
IEC 60601-1 — Medical Electrical Equipment Safety
This is the foundational safety standard for any device that plugs into a wall and touches a patient. It covers electrical shock protection, mechanical hazards, excessive temperatures, electromagnetic compatibility (EMC), and software safety. Every machine we ship is designed and tested to meet IEC 60601-1 requirements — not because every market requires it, but because it’s the right way to build a medical device.
EN 60825-1 — Laser Product Safety Classification
This standard defines laser hazard classes (Class 1 through Class 4) based on accessible emission limits. Our machines are classified as Class 4 laser products — the highest hazard class — and comply with all mandatory safety features: emission indicators, key-controlled operation, remote interlock connector, and protective housing. Compliance with EN 60825-1 is verified during CE testing and is a prerequisite for safe use in any clinical setting.
Additional Compliance Standards
🌍 RoHS (2011/65/EU)
Restriction of Hazardous Substances — our machines are lead-free, mercury-free, and meet all EU environmental requirements for electronic equipment.
📡 EMC Directive (2014/30/EU)
Electromagnetic Compatibility — our machines won’t interfere with other clinic equipment, and they’re immune to reasonable electromagnetic disturbances.
📦 ISO 14971
Risk Management for Medical Devices — we maintain a living risk management file for every product, updated with post-market surveillance data.
📝 ISO 10993 (Biocompatibility)
Biological evaluation of patient-contacting components — treatment heads, handpieces, and sapphire cooling tips are tested for skin contact safety.