Mariana Reis

Regulatory Affairs & Quality Assurance at C-mo Medical Solutions

Speaker

Mariana specialises in Regulatory Affairs and Quality Assurance at C-mo Medical Solutions, a Portuguese start-up that provides cough monitoring solutions for clinical trials and medical practice. She holds a MSc in Regulation and Evaluation of Medicines and Health Products and brings over five years of experience in the medical device industry.
Her expertise includes establishing and maintaining Quality Management Systems compliant with ISO 13485, as well as developing technical documentation of Class I, IIa and IIb medical devices, and regulatory oversight of market products. Mariana leverages her hands-on experience with usability engineering and regulatory documentation to ensure that innovative health technologies meet the highest standards of safety, efficacy and compliance.