Lumenis service partners with customers to ensure regulatory compliance with CMS and Joint Commission standards for medical laser device maintenance. According to updated requirements, maintenance of medical lasers must be done according to the manufacturer's specifications and cannot be managed through alternative programs. To comply with these high standards, Lumenis provides certified engineers trained in FDA, ANSI, ISO, CMS, and Joint Commission requirements who perform comprehensive safety checks during preventative maintenance using original parts.

1. Lumenis service
medical equipment repair

2. Regulatory Compliance
Lumenis Service partners with our customers to ensure safety
and compliance with the latest CMS and The Joint Commission
requirements, the highest quality standards in the industry.
According to the updated CMS4 and The Joint
Commission5 requirements, Medical Laser devices’ maintenance
should be performed according to the manufacturer’s
specifications and is not eligible to be managed via an Alternate
Equipment Management (AEM) program. These regulations
intend to limit potential for injury and inadvertent light exposure
during service of the Medical Laser devices.

3. In order to comply with the highest regulatory
standards Lumenis Service provides you with:
• Service by Lumenis Certified Service Engineers, who embrace
the highest degree of training,
state of-the-art tools, superior process and up-to-date
procedures in place to comply
with FDA 21CFR820, ANSI Z136.3, ISO 13485, CMS and The
Joint Commission
requirements
• Comprehensive compliance and quality management system
based on FDA 21CFR820,
ANSI Z136.3, ISO 13485, CMS and The Joint Commission’s
latest requirements.
For more information about medical equipment repair.

4. In order to comply with the highest regulatory
standards Lumenis Service provides you with:
• Lumenis Service promotes user and patient safety with a
complete safety check during
every Preventative Maintenance Service in accordance with
the manufacturer’s specifications
• Readily available validation and up-to-date computerized
individual equipment history records
to support The Joint Commission requirements.
• Lumenis Service is performed only by manufacturer trained
and certified Service Engineers
who use only original equipment manufacturer (OEM) parts
• A range of offerings to accommodate our customers’ various
financial and risk management priorities.