Always Inspection Ready: Mastering FDA Inspection Preparation and Response
With the FDA increasing unannounced and remote inspections, continuous inspection readiness is more important than ever. This...
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Understanding PDA/ANSI Standard 06-2025: A Roadmap for Culture Change
A robust quality culture is no longer a nice to have—it’s a regulatory and operational imperative. Watch...
Data Integrity in the Age of AI: Securing Connected Devices
As artificial intelligence becomes increasingly embedded in medical devices and healthcare systems, the concept of data integrity...
Human Factors Engineering for Medical Devices From Concept Through Reprocessing and Post-market Surveillance
Human factors engineering (HFE), also referred to as usability engineering, is a structured, risk-based process intended to...
History & Modern Practices for ASTM E1174: Evaluating the Effectiveness of Healthcare Personnel Handwash Formulations
ASTM E1174 was first developed in 1987 and was developed to evaluate Healthcare Personnel Handwash (HCPHW) Formulations...
How QMS Impacts Quality Maturity
In this webinar Susan Schniepp from Regulatory Compliance Associates explores various strategies behind quality maturity. Learn about regulation changes...
How to design an Instruction For Use and validations for EU and US
In this free on-demand webinar, Kathleen Peymen, PhD, Senior Expert, takes you on an road trip to discover...
The Impact of Sterilization Modality on Connected Devices with Electronic Components
devices. The complex nature of connected devices, which often involve a combination of materials and electronic components, can...
Big Changes to ISO 10993 What is happening to the main biocompatibility standard now?
In 2018, TC194, the ISO committee responsible for biocompatibility, released a new version of the 10993-1 standard....