Stuff Sector
Prepared by
S.Santhosh (Admin)
Important questions
share it a link alone
Don't waste my hardwork and valuable time
Don't share as screenshot kind request
**Very important questions are bolded and may be asked based on this topic
don't waste my hardwork and valuable time
Contact uS
*These questions are expected for the exams This may or may not be asked for exams All the best.... from admin Santhosh
Thanks for your love and support guys keep supporting and share let the Engineers know about Us and leave a comment below for better improvements If there is any doubt feel free to ask me I will clear if I can or-else I will say some solutions ..get me through WhatsApp for instant updates ~$tuff$£ctor
SYllabuS
UNIT I INTRODUCTION
Needs finding, problem identification, prior art searches, strategy and concept generation, estimation, sketching, sketch modelling, machine elements, ergonomics and prototyping.
UNIT II DESIGN OF MEDICAL DEVICES & SYSTEM
Medical device classification, bioethics, and privacy, biocompatibility and sterilization techniques, design of clinical , trials, design control and regulatory requirements, introduction to specific, medical technologies: biopotentials measurement (EMG, EOG, ECG, EEG), medical diagnostics (In-vitro diagnostics), medical diagnostics (Imaging), minimally invasive devices, surgical tools and implants.
UNIT III DEVELOPMENT STRATEGY AND PLANNING
Intellectual property strategy – research and development strategy – clinical strategy – regulatory strategy – quality and process management – reimbursement strategy – marketing and stakeholder strategy – sales and distribution strategy – competitive advantage and business strategy.
UNIT IV HARDWARE AND SOFTWARE DESIGN
Hardware design, Hardware risk analysis, Design and project merits, Design for six sigma, software design, software coding, software risk analysis, software metrics, licensing and alternate pathways
UNIT V DESIGN TRANSFER AND IPR
Transfer to manufacturing, documents and deliverables. Standard-ISO, IES, Intellectual Property - Patents, Copy rights, Trademarks, Trade secrets.