Consulting & Support for IEC 60601-1 Compliance
We provide specialized consulting services to help manufacturers and healthcare institutions ensure their medical electrical equipment and laser-based devices meet the essential safety and performance requirements defined by international standards.
Our support covers:
Guidance in preparing technical documentation for regulatory submissions.
Development and review of risk management files in line with ISO 14971.
Assistance with test plan preparation and coordination with accredited laboratories.
Strategic advice to ensure smooth compliance for global market approvals.
Expert consulting on laser device safety according to IEC 60825, covering surgical systems, dermatology equipment, and ophthalmic devices to guarantee safe operation and regulatory acceptance.
IEC 60601-1 is the international benchmark for medical electrical equipment safety. It ensures protection against:
Electrical hazards such as electric shock.
Thermal risks from overheating.
Mechanical hazards related to device design and operation.
Radiation risks, including those from laser technologies.
Consulting & Support for IEC 60825 Compliance
IEC 60825
focuses specifically on laser safety, setting classification rules and protective measures to safeguard patients, healthcare professionals, and the public from hazardous emissions.
Compliance with these standards is not optional—it is a mandatory requirement for regulatory approval in most markets worldwide.
By working with us, clients gain the confidence that their devices are safe, reliable, and ready for international market access.
