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MedTech Summit US

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December 6 - 8, 2022
Intercontinental Chicago Magnificent MileChicago, IL

Stephanie Volk
Senior Corporate Sterilization and Biocompatibility Specialist at ConvaTec

Profile

Stephanie Volk, CISS-RAD is a Senior Corporate Sterilization and Biocompatibility Specialist at ConvaTec, a leader in therapies for the management of chronic conditions including advanced wound care, ostomy care, continence care, critical care, and infusion care. She’s the corporate subject matter expert for Sterilization and Biocompatibility assisting with validation strategies for new products, providing technical support as needed and spearheading global process improvements. She led ConvaTec’s MDR remediation for Biocompatibility which included updating the internal processes to be compliant with the latest regulatory standards, creating global testing strategies and assisting in regulatory submissions.  She currently represents ConvaTec on various AAMI working groups and is a Certified Industrial Sterilization Specialist in Radiation.

Prior to ConvaTec, she worked in the R&D department at K2M Inc (now Stryker Spine), a spinal orthopedic device company, for over 13 years. In her last three years she was a Sr. Project Engineer and the company’s subject matter expert for sterilization, packaging, biocompatibility and cleaning of reusable devices. Prior to that, she served in various development engineering roles for their Minimally Invasive group designing and validation sterile spinal implants and instruments including Cascadia Lateral.

Agenda Sessions

  • Shared Experiences: Creating Effective Biological Evaluation Reports (BEP)

    2:25pm