Medical Device Software Engineering Consulting firm Full Spectrum Software Earns ISO 13485 Certification

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Leading medical device software engineering consulting firm Full Spectrum Software has received ISO 13485 certification. A relatively few medical device software engineering consulting firms have actually achieved ISO 13485 certification. Many medical device makers have ISO 13485 certification and adhere to other ISO standards as well. However, it is somewhat rare for a medical device software engineering consulting firm to achieve the rigorous quality standards and design a Quality Management System required to achieve ISO 13485 certification.

All of our existing clients know how intensely focused and process driven we are in terms of medical device software quality. Achieving ISO 13485certification is another demonstrable benefit to our clients.

Medical device software engineering firm Full Spectrum Software has earned ISO 13485 certification. An ISO 13485:2003 certification from NQA, USA demonstrates Full Spectrum Software’s commitment to provide software engineering and quality assurance services that consistently meet customer and regulatory requirements applicable to the medical device industry, increase customer satisfaction and reduce operating costs through continual improvement of processes and resulting operational efficiencies. ISO 13485 is an increasingly important standard for Full Spectrum Software’s medical device clients.

Andrew Dallas, the president of Full Spectrum Software noted "All of our existing clients know how intensely focused and process driven we are in terms of medical device software quality. Achieving ISO 13485certification is another demonstrable benefit to our clients." ISO 13485 is another commitment to demonstrate Full Spectrum Software’s ability to provide their medical device clients with software engineering services that consistently meet customer and applicable regulatory requirements. It also demonstrates Full Spectrum Software’s commitment to maintaining world-class software engineering and quality processes that consistently meet our customers’ software engineering needs and lowers their overall investment in software engineering and quality assurance services. Full Spectrum Software's medical device portfolio can be viewed here Project Examples

About Full Spectrum Software

Full Spectrum Software is a leading medical device software engineering consulting firm and has designed and developed software for numerous Class III medical devices. Established in 1996, Full Spectrum Software has a large and growing staff of senior computer scientists, senior quality assurance engineers and domain experts in many different clinical specialties. The firm has developed software for clinical areas such as radiation oncology, neurosurgery, CT and PET contrast injection, EEG, EKG, sedation monitoring, polysomnography, remote cerebral monitoring, remote patient monitoring, orthopedics, diagnostics and many others.

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Ken Carson
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