Bhawna Acharya

- Project Leader, Regulatory. Coordinating IVDR compliance-related changes in the organization. - Responsible for management of the integrated project plan and the timeline for the IVDR Regulatory Compliance including quality management systems changes, products IVDR compliance(Analyzers, Automation, Reagents) planning and execution according to design control, product submission and global re-registration, and commercial launch.

-- Project leader. Planning, Prioritising. -- Ensuring the product meets the Engineering Quality Procedures (ISO 13485), Design Controls. -- Driving IEC/ISO standards compliance for products. -- Writing design control requirements for products. -- Incorporating Regulatory requirements in products and design dossier preparation including Technical Files, Essential Requirements. ( EU: MDD, US: FDA 510(k) and other countries submissions)

-- Provided Service to Medical Diagnostic company "Roche Diagnostics Switzerland" for IVD monitoring Cobas 8000 modular analyzer and Cobas 6800 Systems. Also provided services in assessing project compliance with IEC 62304 standard. -- Provided Service to Telecom company "Telenor Norway" for the middleware software project. -- Provided service to "OP Finland" for revamping their banking portal. -- Provided Service to Telecom company T-Mobile Germany for its software.