Credentials & Certifications

Why Is ISO Important?

iso 13485 renew - ReNew BioMedical

Quality is the most important thing we sell at ReNew Biomedical. Our people are important to us and we know their value to our customers. That is why we take so much pride in what we do and how we do it. Having ISO 13485 certification means we never let our guard down and we work hard on offering the best products and services in our industry. Achieving and maintaining ISO 13485 Certification helps us stay above our competition and continue to exceed our customer’s expectations.

 

ISO 13485 is defined as the international standard that specifies requirements for a quality management system (QMS) specific to the medical device industry. Organizations use the standard to demonstrate the ability to consistently provide medical products and services that meet customer and regulatory requirements.”  – International Organization for Standardization

 

Our intention is to always be your first defense in improving the performance and life expectancy of your medical equipment. By externally auditing and challenging our processes, we know our services and reputation raises the bar of our own industry standards. We will remain transparent because we have nothing to hide and only quality service to provide across the board. You can rely on ReNew Biomedical to get it right because we know that lives depend on our performance. View our ISO 13485 Certificate

CABT/CBET Certifications

According to AAMI – Healthcare technology management professionals who desire a CBET certification are expected to have experience in a wide range of electromechanical devices, computers, networks, and software used in healthcare delivery. Generally, candidates desiring this certification may work for medical device manufacturers, hospitals, clinics, home healthcare providers, medical device repair companies, regulatory bodies/agencies, and software manufacturers – such as EMR or device integration providers.

CBETs typically perform some of the following duties on a daily basis:

  • Test and calibrate medical devices (preventive maintenance)
  • Troubleshoot medical devices in a clinical setting and bench/depot setting (corrective maintenance)
  • Manufacture software, parts or devices for use in patient care
  • Ensure compliance with all regulatory processes necessary (i.e. CMS, FDA GMP, etc.
  • Manage medical software/hardware systems (i.e. PACS Administrator, Integration Specialist, Alarm Management, RTLS Systems, etc.)
  • Perform corrective and preventive maintenance on steam systems

Certififed Associates in Biomedical Technology (CABT)

According to AAMI – A certified associate in biomedical technology is an individual who is new to or planning to enter the HTM field and looking to earn an entry-level certification to kick-start their career. In a work setting, this professional will be responsible for scheduled technology maintenance, supporting senior technicians, incoming/routine inspections on new equipment, and minor troubleshooting. Characteristics of a CABT include, but are not limited to: strong communication skills, problem-solving abilities, resourcefulness, strong time management skills, technology insight, highly motivated, and resilience.

Manufacturer Partnerships

ReNew Biomedical’s goal is to provide excellent quality for our customers. We also want to show potential customers who they are partnering with whenever they connect with ReNew. We pride ourselves on the level of quality of our biomedical technicians and are proud to say that they have achieved levels of certification, putting Renew above other competitors.

Our technicians are factory-trained and licensed to work on a variety of  units from our manufacturers, but we have special partnerships with Vyaire and Eitan Medical. Both of these manufacturer partners recognize ReNew’s pursuit of excellence, and have officially certified ReNew as authorized service centers. If you want to know more about our role in these companies, check out our videos here.