Assisting by compiling QMS and fulfilling requirements for a class 2 FDA inspection of Quality system regulations (CFR 820)

Assisting with Quality Management System review, updates, and documentation as per FDA 21 CFR part 820 and ISO 13485:2016

Identifying and implementing pathway to ISO 13485 certification for the company and building a QMS in conformance to ISO 13485:2016 standard

Identifying and implementing pathway for EU MDR CE marking for commercialization in Europe

Interfacing with various global regulatory entities

Contributing to the writing, review, compilation, and submission of required regulatory documentation including QMS SOPs, technical dossier, declaration of conformity and assisting in management reviews and internal audits

Leading Quality and regulatory efforts and communicating with third party QMS software vendors with company specific requirements

Providing regulatory/compliance support to product design and development as well as sales and marketing teams

Evaluating '360DPS' which is a proprietary FDA approved 3D digital planning software and conceptualizing strategic expansion of the scope of the software applications to cater different surgical specialties.

Compiling design requirements and developing a feasible product road map by teaming up with the product development team.

Creating a report of potential applications and expansion of scope of 360Imaging's line of products and services to various surgical specialties considering team, resources, feasibility, and time to market. Developing a commercialization and launch strategy to introduce the expanded scope of products and services

Presenting to surgeons, KOLs, product development and marketing team on the applications of 3D digital planning.

Developing market assessments by validating unmet clinical needs, assessing and documenting feasibility, technology landscape, competitor landscape, market potential, regulatory & reimbursement strategy and commercialization strategies for Georgia tech and Emory University innovators for their early stage novel medical technologies with a mission to foster entrepreneurship and bring University innovations to real patients.

Mentoring BME senior capstone design teams working on real unmet clinical needs to innovate new medical devices. Heading lab sessions which cover topics of Voice of customer, user needs and design inputs, concept and prototype generation, patents and prior art search, verification and validation, risk management, regulatory, quality, manufacturing and commercialization aspects of their projects

• Designed and 3D printed company’s products like Xrayto3D spatial calibration marker and surgical cutting and drilling guides instruments for lower extremity surgeries

• Effectively carried out user needs analysis and understood the clinical aspects to bridge the communication gap between surgeons, stakeholders and product design and development team.

• Attended more than 50 surgeries for beta testing of the product and translating the clinical feedback from surgeons for product development.

• Involved in clinical trials for 3D printed surgical instruments developed for total knee replacement surgeries.

• Benchmarked and documented pre, intra and post operative parameters derived from company’s proprietary cloud based technology ‘Tabplan3D’ with traditional 2D techniques in planning deformity correction surgeries

• Developed a commercialization strategy for pilot sales in India with a focus on achieving product market fit.

• Carried out market needs analysis to forecast future developments and R&D projects to be carried out.

• Managed vendors and B2B relationships.

• Worked closely with top most orthopedic surgeons and Hospitals in India

• Converted CT/MRI/Echo scans to 3D Printable outputs for pre surgical planning.

• Designed products such as surgical guides, implants and orthotics for patient-specific anatomy.

• Set imaging protocols for MRI and CT for 3D Printing usage.

• Worked on new product design & development and rapid prototyping of medical devices

• Clinical immersion by attending various surgeries to find a need or validate a need / product.

• Setup clinical protocols and sterilization protocols for 3D Printed instruments and implants.

• Technology commercialization (technology awareness and adaption) by attending medical conferences, Organizing CMEs for surgeons of various disciplines and delivering seminars at various medical conferences.

• Tutored interns on clinical data management, medical imaging and image processing, human anatomy and designing of 3D Printable anatomical models from imaging data.

• Consulted medical device companies on various additive manufacturing processes, materials and design standards for prototyping and testing using 3D printing.

• Developed and maintained relations by meeting and working closely with surgeons, radiologists and healthcare professionals of various specialties and hospitals across India.