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Erschienen in:

2011 | OriginalPaper | Buchkapitel

19. Translation of New Tissue Engineering Materials to Clinical Application

verfasst von : Benjamin A. Byers, Dolores Baksh

Erschienen in: Biomaterials for Tissue Engineering Applications

Verlag: Springer Vienna

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Abstract

The total product life cycle (TPLC) provides a framework by which medical device companies incorporate international regulatory guidelines and best practices to translate product concepts, including novel biomaterial therapeutics, into clinical and commercial reality. The TPLC emphasizes continuity between all phases of a medical product’s lifetime, including Concept/Feasibility, Design/Development, Validation, Commercialization/Production, Post-Market Surveillance/Support. This product development cadence evolves through definition of the unmet clinical need and market opportunity, application of design control methodologies, consideration of manufacturability and scalability, and execution of the evidence generation and regulatory strategies. Throughout each of these activities, design controls are leveraged to promote cross-functional engagement of sales and marketing, research and development, quality assurance, regulatory affairs, operations and finance to ensure the medical device will provide a safe and efficacious solution for patients and surgeons.

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Vorheriges Kapitel Controlling Stem Cells with Biomaterials

http://www.clinicaltrials.gov/

Foster RN, Kaplan S. Creative destruction: why companies that are built to last underperform the market, and how to successfully transform them. New York: Currency; 2001

Fenton GM, Chi-Ham C, Boettiger S. Freedom to operate: the law firm’s approach and role. In: Krattiger A, Mahoney RT, Nelson L et al. editors. Executive guide to intellectual property management in health and agricultural innovation: a handbook of best practices. Oxford, UK: MIHR and Davis, USA: PIPRA; 2007. Available from: http://www.ipHandbook.org

http://www.astm.org/

Code of Federal Regulations Title 21 Part 812 (Investigational device exemptions). Available from: http://www.fda.gov/

Code of Federal Regulations Title 21 Part 58 (Good laboratory practice for nonclinical laboratory studies). Available from: http://www.fda.gov/

Code of Federal Regulations Title 21 Part 820 (Quality system regulation). Available from: http://www.fda.gov/

ISO 13485:2003 (Medical devices – quality management systems – requirements for regulatory purposes). Available from: http://www.iso.org/iso/home.html

Code of Federal Regulations Title 21 Part 820 Subpart C (Quality system regulation – design controls). Available from: http://www.fda.gov/

10.

Teixeira MB, Bradley R. Design controls for the medical device industry. Boca Raton: CRC Press; 2003

11.

Code of Federal Regulations Title 21 Part 860 (Medical device classification procedures). Available from: http://www.fda.gov/

12.

ISO 10993. Available from: http://www.iso.org/iso/home.html

13.

Code of Federal Regulations Title 21 Part 820 Subpart G (Quality system regulation – production and process controls). Available from: http://www.fda.gov/

14.

Code of Federal Regulations Title 21 Part 807 Subpart E (Establishment registration and device listing for manufacturers and initial importers of devices – premarket notification procedures). Available from: http://www.fda.gov/

15.

Code of Federal Regulations Title 21 Part 814 (Premarket approval of medical devices). Available from: http://www.fda.gov/

16.

http://clinicaltrials.gov/ct2/info/glossary

17.

Code of Federal Regulations Title 21 Part 3.2(e) (Product jurisdiction – definitions – combination products). Available from: http://www.fda.gov/

18.

Code of Federal Regulations Title 21 Part 3.7 (Product jurisdiction – request for designation). Available from: http://www.fda.gov/

19.

Code of Federal Regulations Title 21 Part 312 (Investigational new drug application). Available from: http://www.fda.gov/

20.

Code of Federal Regulations Title 21 Parts 600, 601 and 610 (Regulations regarding BLAs for therapeutic biological products). Available from: http://www.fda.gov/

21.

Code of Federal Regulations Title 21 Part 314 (Applications for FDA approval to market a new drug or an antibiotic drug). Available from: http://www.fda.gov/

Titel: Translation of New Tissue Engineering Materials to Clinical Application
verfasst von: Benjamin A. Byers
Dolores Baksh
Verlag: Springer Vienna
Buch: Biomaterials for Tissue Engineering Applications
Print ISBN: 978-3-7091-0384-5

Electronic ISBN: 978-3-7091-0385-2

Copyright-Jahr: 2011
DOI: https://doi.org/10.1007/978-3-7091-0385-2_19

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