Prashant Dalvi

Certified ISO 13485:2016 Medical Device-Quality Management System Lead Auditor and Bio-Medical Engineer with 10 years of experience in medical device industry, specializing in global regulatory submissions, medical device complaint handling and project management. Proven ability to create and review technical and clinical files for medical devices. Demonstrates a strong technical expertise in managing health authority queries, and ensuring compliance with international standards.

Adept at working in dynamic environments and collaborating effectively with cross functional global teams.

• Regulatory Affairs: Plan and execute regulatory strategies for assigned products, ensure products remain compliant with all relevant regulatory requirements throughout their product life cycle.
• Product Registrations & Submissions: Coordinate with regulatory agencies for reports submitted and for approval of pending registrations.
• Collaboration with CFT’s: Collaborating and partnering with cross functional teams like R&D, quality, regulatory, and manufacturing teams to ensure smooth completion of milestones and deliveries.
• Health Authorities Interactions: Check and respond to feedback received from notified bodies on a timely basis. Request missing documents that is required from supplier via supplier quality management team.
• Complaint Handling: Responsible for investigating and handling medical devices complaints on a daily basis and create a detailed report by identifying the root cause.
• Risk Management: Deep analysis of risks associated in overall usage for medical device right from production to duration of use and till disposal.
• Preventive and Corrective Measures: Creation of review checklist for ensuring defect free technical files. Creation and gap analysis of technical templates as per ISO 13485 and 21 CFR 820.
• Project Management: Working as a part of project management, responsible for resource management, timely completion of projects, budget, ROI calculations and cost estimation, review milestones. Responsible to plan, track and monitor project plans for high-risk class medical devices and report to HODs.
• Training and Leadership: Provide leadership guidance (including technical training) to other members of the project. Showcasing current projects and forecasted projects to the team members, and other stakeholders. Lead and participate in continuous improvement activities across the organization.
• Quality Management: Participate in internal audits to check and implement QMS and ensure quality standards in all projects assigned. Participate and suggest improvement activities within the organization.
• Subject Matter Expert: Working as an SME for technical files like product description and biocompatibility, and provide continuous updates to the team as an when received from client.
• Medical Devices Handled: Expertise in handling technical files for medical devices like orthopedics implants and instruments, dental and ENT products, active as well as non-active medical devices.
• International Standards: Expertise in interpreting and implementing various medical device standards and guidance's, such as ISO 14971-1, IEC 62366-1, ISO10993-1, IEC 60601-1 and MEDDEV 2.7/4.

Bachelors in Bio-Medical Engineering