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Full Product Details

Author:   Vinny R. Sastri (President, Winovia, LLC, USA) ,  Vinny R. Sastri (President, Winovia, LLC, USA)
Publisher:   William Andrew Publishing
Imprint:   William Andrew Publishing
Edition:   3rd edition
Weight:   1.590kg
ISBN:  

9780323851268

ISBN 10:   0323851266
Pages:   524
Publication Date:   25 November 2021
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   Manufactured on demand  
We will order this item for you from a manufactured on demand supplier.

Table of Contents

1. Introduction to Plastics in Medical Devices 2. Regulations of Medical Devices and Application to Plastic Suppliers 3. Materials used in Medical Devices 4. Material Requirements for Plastics used in Medical Devices 5. Commodity Thermoplastics PVC, POE, PS for Medical Devices 6. Engineering Thermoplastics Acrylics, PC, PC, PU, Polyacetals, Polyesters, Polyamides for Medical Devices 7. High Temperature Engineering Thermoplastics for Medical Devices 8. Other Polymers: Styrenics, Silicones, TPEs, Biopolymers and Thermosets for Medical Devices 9. Polymer Additives Used to Enhance Material Properties for Medical Device Applications 10. Materials used for Coatings, Adhesives and 3-D Printing in Medical Devices 11. Purchasing Controls and Supplier Controls in Plastics for Medical Devices 12. Process Validation in Plastics for Medical Devices 13. Risk Management and Biocompatibility in Plastics for Medical Devices

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Author Information

Vinny Sastri, Ph.D., is the President of Winovia, LLC, a consultancy company specializing in quality management systems, notably in the area of medical devices. Dr. Sastri’s areas of expertise include FDA and ISO quality management systems for medical devices and pharmaceuticals, product development processes, design controls, manufacturing and process validation, risk management, six sigma and design for six sigma, CA/PA, and materials. He is a certified Six Sigma black-belt, and has a strong track record in leading, managing, establishing and implementing growth and quality initiatives into client organizations around the world, resulting effective quality management systems and operational excellence. Dr. Sastri was on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training (along with the FDA) on the FDA Quality Systems Requirements and Industry Practice, Design Controls, Process Validation and Risk Management to the medical device industry. He now conducts public and in-house training through his company Winovia LLC. Prior to starting Winovia, Dr. Sastri held global leadership positions in technology, quality, manufacturing and marketing in companies including BASF, AlliedSignal and General Electric. He earned a Ph.D. from Rutgers University, completed post-doctoral work at Brooklyn Polytechnic Institute, and was an Adjunct Professor at Virginia Commonwealth University in Richmond, Virginia. Dr. Sastri has over 20 publications and 6 patents, and has presented at many international conferences and webinars in the United States, Europe, and Asia.

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