Our objective is to provide our clients the technology resources they need to maximize their return on investment.
Calimex USA is a software company with extensive experience and expertise in the healthcare industry and particularly in blood banking, delivering first-class software, scripts, interfaces, embedded software, and other innovative technologies that meet regulatory compliance requirements.
Software services we offer
- Automation of Manual Processes.
- Applications, Interfaces, Scripts.
- Develop realistic wireframes and interactive UI.
- Software Testing and Validation.
- Software Change Control Development.
- Industry specific application integration.
With our expertise in professional design, development, testing and maintenance, Calimex gives your organization the edge with services inspired by industry trends and using the latest technologies. Designing and developing web and window applications from simple to complex has been the focus of our highly skilled designers and developers.
COMPLIANCE | FDA CONSULTANCY SERVICES | 21 CFR PART 820 | FDA 510(K) PROCESS
FDA provides valuable services to ensure that all food is safe & all medical products are safe and effective and the public health is advanced and protected. It's mission is protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.
Calimex USA is a Medical Device Establishment registered with FDA. We have three software applications registered as medical devices with FDA 510(k) approvals and one registered as a Class I medical device and we provide FDA consultancy services to large international companies world-wide.
Our services include
- Providing consultancy services on software design, network and infrastructure architecture including mobile devices for EMC, EMI, RF.
- Software Quality Assurance, cGMP.
- Compliance to 21 CFR Part II, 21 CFR Part 820 and taking their medical devices through the FDA 510(k) processes.
We are affiliated with leading blood bank software vendors such as MAK Systems, Haemonetics and can recommend and implement the necessary systems, including SafeTrace® and SafeTrace TX®, ElDorado Donor®, eProgesa and other top notch BECS.
Rising cost of healthcare, increased adoption of technology, prevalence of quality and performance are forcing the healthcare industry to recast business and care delivery processes. Whether it is a hospital, a blood bank, a laboratory or a biotech company, our objective is to provide our customers with the technological resources they need to maximize their ROI. Our Quality of Service can be FDA compliant.
HOSTING MAINTENANCE | PREVENT A SECURITY BREACH BY KEEPING DATA OUT OF REACH
Calimex USA offers complete cyber security solutions, by meeting the ongoing need for holistic security within the ever-growing IT Security market. Our experts specialize in security auditing, penetration testing, forensics, Incident Response and Architecture Review. Our group of leading security professionals include senior security consultants, leading security instructors provides network peace keeping for agencies and corporations worldwide.
We keep up-to-date on the latest security protocols and technology to ensure our customers/clients websites and portals are safe and secure.
IT INFRASTRUCTURE & OPERATIONS
- IT Security.
- Modernization and Consolidation (Cloud, Colocation and Data Migration).
- Disaster Recovery
- Server and Desktop Virtualization.
- Networking – LAN, WAN, MAN.
- Support Center.
Calimex USA advise on your cybersecurity strategy depending on your current level of maturity to help you define your security perimeter, objectives and procedures. Our full range of cybersecurity consulting services will help you protect your systems, detect threats and respond to cyber security incidents.Our experts are certified in Information Security Management (CISM), Risk and Information Systems Control (CRISC).