Bhanu Shanker Chandragiri

• PTR gap analysis for China re-registration, as per technical documentation.
• Sustenance activities for the manufacturer site change in Europe and document compliance updates as per quality standards.
• Technical documentation update to keep in accordance with quality standards due to site changes for Class I and II medical devices.
• Gap analysis and change control activities for surgical devices (endoscopic devices). Various change assessment, gap analysis activities, as per different markets, for design and regulatory compliance.
• Knowledge of investigations that involve trend review, device history review, root cause analysis, and complaints summary based on the device failure. • Creation of EU MDR Technical Documentation and Global Submission Summary Documentation - EU MDR 2017/745. (Class III and Active Implantable Medical Devices)
• GSPR creation as per Annex I, EU MDR.
• Responsible for EU MDR STED creation and review of technical files (Class IIa, IIb, III).
• Preparation of SoP and checklists for EU MDR STED documentation, and country-specific submissions.

• New product design and development.
• Developed complete process drawings for coronary stents, PTCA catheters, diagnostic catheters, balloons, and cardiac assist devices.
• Contributed across the full product development lifecycle, coordinating R&D deliverables, and collaborating with cross-functional teams, including Marketing, Quality, Regulatory (ISO 13485, US FDA), Manufacturing, and Operations.
• Executed DQ, IQ, OQ, and PQ validations in compliance with medical device regulatory standards.
• Managed complaint investigation and documentation using electronic quality management systems, ensuring regulatory compliance.
• Attended clinical procedures (operating theaters) to evaluate device performance, collect user feedback, and support complaint resolution.
• Engaged with customers, healthcare professionals, and vendors to provide technical support and resolve product issues.
• Delivered robust design solutions, meeting customer and regulatory requirements, with full design traceability.
• Optimized product design, material selection, manufacturing processes, and human factors to improve safety, performance, and manufacturability.
• Applied engineering analysis and design controls to enhance product reliability and business outcomes.
• Led technical ownership of product design for both developmental and commercial medical device platforms.
• Designed special concepts and rapid prototypes, including special-purpose machines, to support production and process improvements.
• Recognized for developing Device Master Records (DMR) from concept through commercialization.

• Sama techno cast is a manufacturing of seam less pipes, metal gaskets, and all type of Ball valves, SMS union, plug valves, flow control valves, flow diversion valve, non-return valves and it owns a foundry unit (centrifugal casting and sand casting).

• DHF remediation of Class I, II, and III medical devices, ensuring compliance with US FDA regulation 21 CFR 820.30.

• Performed gap analysis on existing design control documents, ensuring all design and development records are up to date and compliant.

• Creation of trace matrix, verification and validation matrix, label review, drawings review, technical reports, protocols, special reports, and rationale reports.

Overhaul design input and output documents, such as the system and subsystem requirements document, BOM, drawings, and process control specifications for remediation.