Fda And The Medical Device Industry

FDA and the Medical Device Industry PDF
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
Category : Heart valve prosthesis industry
Languages : en
Pages : 626
View: 224

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Book Description:


Fda And The Medical Device Industry

FDA and the Medical Device Industry PDF
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
Category : Heart valve prosthesis industry
Languages : en
Pages : 626
View: 7530

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Book Description:


The Medical Device Industry

The Medical Device Industry PDF
Author: Norman F. Estrin
Publisher: CRC Press
Category : Medical
Languages : en
Pages : 976
View: 4130

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Book Description:
Practical information about the complexities of biomedical technology and regulation, and their implications for manufacturers and marketers of health care devices. Written primarily for those in the industry concerned about staying competitive in light of complex and fluctuating regulatory approach


The Medical Device Industry

The Medical Device Industry PDF
Author: John Burton
Publisher: Cambridge Scholars Publishing
Category : Law
Languages : en
Pages : 200
View: 1891

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Book Description:
The Medical Device industry is one of the fastest growing industries in the world. Device manufacturers are producing increasingly sophisticated and complex medical device software to differentiate themselves in the battle for dominance in this sector. The increase in the complexity of medical device software has introduced new challenges with respect to making medical devices and their associated software safe. Risk management has emerged as key in addressing these challenges. Existing literature on risk management for medical devices has been slow to adequately account for the complex nature of software in modern medical devices. Conversely, excellent progress has been made in the broader Software Engineering community with the production of holistic software risk based models such as the Capability Maturity Model Integration (CMMI®) and SPICE™. However, these models do not account for medical device specific requirements. This book examines the possibility of a unified approach whilst investigating the relevance of the CMMI® SPI model to the medical device regulatory requirements.