Petra Elischer

Hart Biologicals Limited

BIOGRAPHY

Petra Elischer is the quality and regulatory affairs professional at the forefront of the medical device and IVD industry, with over 10 years of experience. She is an ISO 13485 lead auditor, PRRC, and IVDR practitioner, bringing deep expertise in compliance and quality systems.

Petra is a subject matter expert in sterilisation, microbiology, and cleanroom environments, with a special focus on procedure packs and surgical room clothing. Her work ensures product safety and regulatory alignment across highly controlled healthcare setting