Veeresh Puttaswamy

- Quality management according to ISO 13485/EU-MDR in production, and clinical investigation. - Manage overall Risk Assessment process (product, process, infrastructure. - Ensuring quality and the correct implementation of processes and systems. - Preparation and monitoring of audits by Notified bodies, authorities, and customers. - Monitoring and implementation of regulatory requirements in cooperation with (labeling, MDR requirements for Class III implantable and custom-made devices)

- Organizing and maintaining training records, supplier management, also monitoring the validation process (Product, process, and software) - Monitor and maintain the effective implementation of CAPA and non-conformity. - QC, creating the batch records. Handle the Post-processing(Cleaning, packaging, and sterilization) -Supply chain management including the final release of the product and delivery to the customer - Execute microbiological monitoring of the cleanroom environment and personnel monitoring