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...
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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....
Parenteral Drug Development Exploring the Potential Benefits of Terminal Sterilization
In this insightful webinar, originally presented at Pharmapack Europe 2022, S. Ross Tsakas, Pharmaceutical Segment Leader at...
DHF and Design Control
In this episode, host Brandon Miller is joined by Jessica Schafersman, a Biomedical Engineer, Project Management Professional,...
Outsourcing and Staff Augmentation
In this episode, host Brandon Miller is joined by Erica Porcelli, CEO of Regulatory Compliance Associates (RCA),...
What is ISO13485
In this episode, host Brandon Miller is joined by Jordan Elder, Director of Regulatory Affairs at Regulatory...
The Road to Market Authorization for Sterile Medical Devices within the European Union
Sterile medical devices must adhere to the regulations and standards for CE marking that came into effect...