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CFR 21, Parts 800 to 1299, Food and Drugs, April 01, 2017 (Volume 8 of 9)


Code of Federal Regulations Title 21, Volume 8, April 1, 2017 contains regulations governing Food and Drugs and may also be referenced as:- Code of Federal Regulations Title 21, Volume 8, April 1, 2017- CFR Title 21- CFR 21, Food and Drugs- CFR 21, Parts 800 to 1299, Food and DrugsThis volume contains Parts 800 to 1299:- Part 800; GENERAL- Part 801; LABELING- Part 803; MEDICAL DEVICE REPORTING- Part 806; MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS- Part 807; ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES- Part 808; EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS- Part 809; IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE- Part 810; MEDICAL DEVICE RECALL AUTHORITY- Part 812; INVESTIGATIONAL DEVICE EXEMPTIONS- Part 813; Reserved- Part 814; PREMARKET APPROVAL OF MEDICAL DEVICES- Part 820; QUALITY SYSTEM REGULATION- Part 821; MEDICAL DEVICE TRACKING REQUIREMENTS- Part 822; POSTMARKET SURVEILLANCE- Part 830; UNIQUE DEVICE IDENTIFICATION- Part 860; MEDICAL DEVICE CLASSIFICATION PROCEDURES- Part 861; PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT- Part 862; CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES- Part 864; HEMATOLOGY AND PATHOLOGY DEVICES- Part 866; IMMUNOLOGY AND MICROBIOLOGY DEVICES- Part 868; ANESTHESIOLOGY DEVICES- Part 870; CARDIOVASCULAR DEVICES- Part 872; DENTAL DEVICES- Part 874; EAR, NOSE, AND THROAT DEVICES- Part 876; GASTROENTEROLOGY-UROLOGY DEVICES- Part 878; GENERAL AND ...

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The development of medical technology in the last years of the 20th century has been very dynamic. Synthetic single-use products, artificial joint replacements, pacemaker technologies or minimal-invasive procedures result in a high standard of medical care. But despite of the huge progress in this field, we are presumably only at the beginning of a medical technology revolution.The 1st version of the German Medizinproduktegesetz (MPG, Medical Devices Act) came into effect on January 1, 1995. It represents the national implementation of the European directives 90/385/EEC for active implantable medical device, 93/42/EEC for medical devices and 98/79/EEC for in vitro diagnostic devices.With the implementation of this act in the EU internal market, the free movement of medical devices was established. Medical devices that are marketable in one member state of the EU are also marketable in the other EU countries. Manufacturers of medical devices can therefore place their products on the whole EU market.The CE-mark on the products is the proof of complying with the essential requirements. The Medical Devices Act guarantees the efficacy and safety of the medical device because the product has to undergo comprehensive control procedures during the design and manufacturing process. The CE-mark is a cachet for quality and efficacy. After the market access, the authorities take care of the safety for users and consumers via definition of essential requirements.This book presents the maj...

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Elisabetta Ceretti Biomedical Devices. Design, Prototyping, and Manufacturing


Biomedical Devices: Design, Prototyping, and Manufacturing features fundamental discussions of all facets of materials processing and manufacturing processes across a wide range of medical devices and artificial tissues. Represents the first compilation of information on the design, prototyping, and manufacture of medical devices into one volume Offers in-depth coverage of medical devices, beginning with an introductory overview through to the design, manufacture, and applications Features examples of a variety of medical applications of devices, including biopsy micro forceps, micro-needle arrays, wrist implants, spinal spacers, and fixtures Provides students, doctors, scientists, and technicians interested in the development and applications of medical devices the ideal reference source

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