Field notes from the front line of quality.
Practical guidance from Globiox SMEs — FDA readiness, auditing, CAPA, validation, and quality systems for regulated life sciences.
Challenges of the Medical Device Market for New Manufacturers
Written by: Andrey Grishin, MD, Globiox Consultant Ensuring Quality of the Final Product. Every Medical device manufacturer must guaranty high product quality…
September 10, 2019Medical DevicesClinical Evaluation Reports (CER) –
Written by: Daniel Miranda, Globiox Consultant Clinical evaluation is a critical, ongoing task that must be performed by medical device manufacturers who…
May 30, 2019Medical DevicesAlmost There: Safety and Performance Pathway Option for 510(k) Submissions
Written by: Daniel Miranda, Globiox Consultant On 1/22/2019, the FDA posted their final guidance describing the Safety and Performance Pathway option for…
February 18, 2019Medical DevicesDesign Control
Editor’s note (August 2026): On February 2, 2026, FDA’s Quality Management System Regulation (QMSR) replaced the Quality System Regulation, incorporating ISO…
August 14, 2013FDA & ComplianceCombined use diagnostic instruments and the FDA’s thoughts
The FDA has recently released a draft guidance entitled “Molecular Diagnostic Instruments with Combined Functions.” The recommendations display intent to…
May 15, 2013Ready to get inspection-ready?
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