All posts by: Nikki DeLellis

About Nikki DeLellis

Acertara Receives ISO/IEC 17025:2017 Certificate of Accreditation

LONGMONT, CO June 3, 2019. Acertara Acoustic Laboratories, an independent ISO/IEC 17025:2017 accredited medical ultrasound acoustic measurement, testing, and calibration laboratory, and ISO13485:2016 certified probe repair and new product development facility announces it has received the latest version of accreditation from the ANSI National Accreditation Board for ISO/IEC 17025:2017 for ultrasound acoustic testing and calibration. … Continue reading

June 3, 2019 Uncategorized

The FDA 510(k) Guidance

Rules, Regulations, Compliance, Substantial Equivalence, or What? G. Wayne Moore, B.Sc., MBA, FASE 05/14/19 As an ultrasound medical device regulatory expert, I receive a great many questions throughout the year regarding exactly what the FDA Guidance documents are. For example, are they requirements, rules, suggestions, or regulations? Below you will find the link to the … Continue reading

May 13, 2019 Newsletter

Philips xMatrix Repair Capabilities

Acertara has redefined its repair capabilities on Philips X5-1 xMatrix transducers.  Repair capabilities include cosmetic repairs, lens replacements, CW mitigation, re-termination, and complex electrical repairs on both the explora and compact connectors. We have also expanded our inventory to include loaners for both models.  Call the main office at 303-834-8413 or email us at Acertara_cares@Acertaralabs.com for your … Continue reading

March 11, 2019 Newsletter

Human Visual Acuity

The Human Eye versus AI G. Wayne Moore, B.Sc., MBA, FASE 02/12 /19 Medical images are often comprised of both subjective and objective interpretation components. This is true because each type of imaging modality has strengths and weaknesses ranging from the breadth of clinical use to what humans perceive as image resolution. Medical imaging devices … Continue reading

February 11, 2019 Newsletter