Design Controls for the Medical Device Industry, Third Edition (PDF)
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This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and ISO 9001:2015 and 13485:2016 standards, but also meets today's Notified Body auditors' and FDA investigators' expectations. Areas addressed are design planning, input, output, review, verification, validation, change, transfer and history. The FDA Quality System Inspection Technique (QSIT) is also covered in-depth.
Before beginning this venture, she was Director of Quality Assurance and Regulatory Affairs at Bioderm, Inc., a start-up medical device company in the Tampa Bay Florida area where she designed, directed and implemented the policies and procedures that established this company's compliance with global regulatory requirements.
Ms. Teixeira was also Quality Systems Manager for Regulatory Affairs at Smith & Nephew's Wound Management Division in Largo, Florida. In addition to directing the planning, development and implementation of Smith & Nephew's ISO 13485, FDA GMP, and MDD 93/42/EEC regulatory efforts, she implemented and directed the company's internal audit program and management review system. It was her direction and guidance that allowed Smith & Nephew's Wound Management Division to achieve ISO certification in less than a year, as well as their MDD certification one year later.
Ms. Teixeira began her career as a Quality Engineer for Raytheon, GTE Government Systems and Sparton Electronics. During her tenure at these companies she was responsible for establishing and implementing quality assurance programs and procedures, leading supplier and customer audits, developing and performing quality system and auditor training, initiating and managing corrective actions, and developing and implementing supplier certification programs. During her tenure at Sparton, she managed the company through its initial ISO certification and subsequent surveillance audits.
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- Autor: Marie B. Teixeira
- 2019, 3. Auflage, 262 Seiten, Englisch
- Verlag: Taylor & Francis
- ISBN-10: 1351261479
- ISBN-13: 9781351261470
- Erscheinungsdatum: 02.08.2019
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