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Angelo Di Perna has extensive experience in regulatory affairs, quality assurance, and sterilization within the medical device industry. With a background in engineering, Angelo has worked with various companies such as CR Bard, Baxter International Inc., and optimed Medizinische Instrumente GmbH in roles such as Regulatory Affairs Contractor, Sterilization Expert, and Interim Sterilization Manager. Angelo has been involved in projects related to EU MDR remediation, CE marking, and technical documentation generation. Angelo's expertise lies in risk management, design verification and validation, and gap assessments for regulatory compliance.