Bücher zum Thema „Medical device validation“

Vercimak, Sutton Charmaine, Hrsg. Validation for medical device and diagnostic manufacturers. 2. Aufl. Buffalo Grove, Ill: Interpharm Press, 1998.

Medical device software verification, validation and compliance. Norwood, Mass: Artech House, 2011.

Vercimak, Sutton Charmaine, Hrsg. Validation for medical device and diagnostic manufacturers. 2. Aufl. Buffalo Grove, IL: Interpharm Press, 1994.

Haider, Syed Imtiaz. Validation standard operating procedures: A step-by-step guide for achieving compliance in the pharmaceutical, medical device, and biotech industries. 2. Aufl. Boca Raton: Taylor & Francis, 2006.

Dills, David. Technical guide: Conducting effective medical device validations. Royal Palm Beach, FL: Institute of Validation Technology, 1999.

Dills, David. Technical guide: Conducting effective medical device validations. Royal Palm Beach, FL: Institute of Validation Technology, 1999.

Lopez, Orlando. Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation. Boca Raton : Taylor & Francis, [2018]: Productivity Press, 2018. http://dx.doi.org/10.4324/9781315174617.

The Medical Device Validation Handbook, Second Edition. Regulatory Affairs Professionals Society (RAPS), 2018.

Pharmaceutical and Medical Device Validation by Experimental Design. Informa Healthcare, 2007.

Torbeck, Lynn D., Hrsg. Pharmaceutical and Medical Device Validation by Experimental Design. CRC Press, 2007. http://dx.doi.org/10.3109/9781420055702.

Chamberlain, Richard L. Computer Systems Validation for the Pharmaceutical & Medical Device Industries. 2. Aufl. Interpharm Pr, 1994.

Desain, Carol V., und Charmaine V. Sutton. Validation for Medical Device and Diagnostic Manufacturers, Second Edition. 2. Aufl. Informa Healthcare, 1997.

Chamberlain, Richard. Computer Systems Validation for the Pharmaceutical and Medical Device Industries. 2. Aufl. Interpharm Pr, 1994.

Computer Systems Validation for the Pharmaceutical and Medical Device Industries. Alaren Press, 1994.

Farb, Daniel. Pharmaceutical Computer Validation Introduction Library Edition: Gmp (Good Manufacturing Practices) Training Introduction to Meet Fda Regulations in the ... in Pharmaceutical, Medical Device, Food, and. University Of Health Care, 2004.

Farb, Daniel. Part 11 and Computer Validation Library Edition: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, for Pharmaceutical, Medical Device, Food, and Cosmetics Manufacturing. University Of Health Care, 2004.

Gordon, Bruce, und Daniel Farb. GMP Training Package Manual and CD, The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... System Validation and Part 11, Covering FD. UniversityOfHealthCare, 2003.

Process Validation for Medical Devices (Drugs and the Pharmaceutical Sciences). Marcel Dekker Inc, 2006.

Carr, Paul W., und Kevin Schinze. Proceedings: Validation of Cleaning Procedures for Medical Devices and Bulk and Finished Drugs , Processes and Facilities. Training Dynamics Healthcare Div, 1994.

Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices: Process Design, Validation, Routine Sterilization, and Contract Sterilizati. Assn for the Advancement of Medical, 1988.

Great Britain. Medical Devices Directorate., Hrsg. Animal tissues in medical devices: Guidance on the control of source materials, and the validation and routine control of chemical methods used for sterilization. London: HMSO, 1993.

Center for Drug Evaluation and Research (U.S.), Hrsg. Guideline on validation of the Limulus Amebocyte Lysate test as an end-product endotoxin test for human and animal parenteral drugs, biological products, and medical devices. Rockville, MD: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, 1987.