Inspection of Medical Devices
Title | Inspection of Medical Devices PDF eBook |
Author | Almir Badnjević |
Publisher | Springer Nature |
Pages | 441 |
Release | 2023-12-28 |
Genre | Technology & Engineering |
ISBN | 3031434447 |
This comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance—a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered—welcome to the future of healthcare!
Inspection of Medical Devices
Title | Inspection of Medical Devices PDF eBook |
Author | Almir Badnjević |
Publisher | Springer |
Pages | 285 |
Release | 2017-10-26 |
Genre | Technology & Engineering |
ISBN | 9811066507 |
This book offers all countries a guide to implementing verification systems for medical devices to ensure they satisfy their regulations. It describes the processes, procedures and need for integrating medical devices into the legal metrology framework, addresses their independent safety and performance verification, and highlights the associated savings for national healthcare systems, all with the ultimate goal of increasing the efficacy and reliability of patient diagnoses and treatment. The book primarily focuses on diagnostic and therapeutic medical devices, and reflects the latest international directives and regulations. Above all, the book demonstrates that integrating medical devices into the legal metrology system and establishing a fully operational national laboratory for the inspection of medical devices could significantly improve the reliability of medical devices in diagnosis and patient care, while also reducing costs for the healthcare system in the respective country.
Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections
Title | Medical Devices: Challenges for FDA in Conducting Manufacturer Inspections PDF eBook |
Author | Marcia Crosse |
Publisher | DIANE Publishing |
Pages | 30 |
Release | 2008-05 |
Genre | Business & Economics |
ISBN | 1437900208 |
As part of the FDA¿s oversight of the safety & effectiveness of medical devices marketed in the U.S., it inspects domestic & foreign establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee & Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two such voluntary programs. This statement: (1) assesses FDA¿s mgmt. of inspections of establishments -- particularly those in foreign countries -- manufacturing devices for the U.S. market; & (2) provides the status of FDA¿s programs for third-party inspections of medical device manufacturing establishments. Illustrations.
Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments
Title | Medical Devices: FDA Faces Challenges in Conducting Inspections of Foreign Manufacturing Establishments PDF eBook |
Author | Marcia Crosse |
Publisher | DIANE Publishing |
Pages | 26 |
Release | 2008-12 |
Genre | Health & Fitness |
ISBN | 1437905277 |
As part of the FDA oversight of the safety and effectiveness of medical devices marketed in the U.S., it inspects certain foreign and domestic establishments where these devices are manufactured. To help FDA address shortcomings in its inspection program, the Medical Device User Fee and Modernization Act of 2002 required FDA to accredit third parties to inspect certain establishments. In response, FDA has implemented two voluntary programs for that purpose. This statement assesses: (1) FDA¿s program for inspecting foreign establishments that manufacture medical devices for the U.S. market; and (2) FDA¿s programs for third-party inspections of those establishments.
Usability Testing of Medical Devices
Title | Usability Testing of Medical Devices PDF eBook |
Author | Michael E. Wiklund, P.E. |
Publisher | CRC Press |
Pages | 472 |
Release | 2015-12-23 |
Genre | Medical |
ISBN | 1466595892 |
Usability Testing of Medical Devices covers the nitty-gritty of usability test planning, conducting, and results reporting. The book also discusses the government regulations and industry standards that motivate many medical device manufacturers to conduct usability tests.Since publication of the first edition, the FDA and other regulatory groups h
Medical Devices: Status of FDA’s Program for Inspection by Accredited Organizations
Title | Medical Devices: Status of FDA’s Program for Inspection by Accredited Organizations PDF eBook |
Author | |
Publisher | DIANE Publishing |
Pages | 28 |
Release | |
Genre | |
ISBN | 9781422313732 |
Device Good Manufacturing Practices
Title | Device Good Manufacturing Practices PDF eBook |
Author | United States. Bureau of Medical Devices |
Publisher | |
Pages | 96 |
Release | 1978 |
Genre | Medical instruments and apparatus |
ISBN |