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...
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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...
Quality Culture at the Crossroads: Building a Culture of Quality for Increased Success
In this webinar, Susan Schniepp, distinguished fellow at Regulatory Compliance Associates®, will delve into effective approaches for...
2022 Industry Outlook Medical Device
In this episode, host Brandon Miller is joined by Seyed Khorashahi and Thor Rollins to explore the...
Laboratory Out of Specification Investigations
In this episode, host Brandon Miller is joined by Walter Mason, Senior Director of Quality Control and...