The design process for medical devices is highly regulated to ensure the safety of patients. Thispaper will present a review of the design process for implantable orthopedic medical devices. It will cover themain stages of feasibility, design reviews, design, design verification, manufacture, design validation, designtransfer and design changes.

Vipul Vijay Ruiwale

School of Mechanical Engineering

Engineering and Technology

MIT-World Peace University (MIT-WPU) is a top educational institute located in Pune, India. It is recognized within&nbsp;UGC under Government of Maharashtra Act No. XXXV 2017.&nbsp;

It is part of the MIT group of institutions (established in 1983) which covers 10+ campuses across India and has more than 50,000+ students enrolled across various disciplines at a given point of time. The institute houses 15 schools ranging from Engineering &amp; Technology, Design, Pharmacy, Commerce, Governance among others. It offers undergraduate, postgraduate and PhD programs among different disciplines.&nbsp;

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MIT World Peace University

IOSR Journal of Mechanical & Civil Engineering

Handbook of Medical Device Regulatory Affairs in Asia

ISO 13485:2003/2016—Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes

Class 1 Devices

Essential Requirements11EC (1993) Medical Devices Directive 93/42/EEC as amended by 2007/47/EC.

Finite Elements in Analysis and Design

Modeling metal deposition in heat transfer analyses of additive manufacturing processes

International Journal of Biomaterials

Next Generation Orthopaedic Implants by Additive Manufacturing Using Electron Beam Melting

The Open Biomedical Engineering Journal

A Review of the Design Process for Implantable Orthopedic Medical Devices

A Review on Design Process of Orthopedic Implants

Journal	IOSR Journal of Mechanical & Civil Engineering
Publisher	IOSR Journal of Mechanical and Civil Engineering (IOSR-JMCE)
Open Access	No