Microsoft 70-341 Microsoft Certified Professional Exam Dumps

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The Microsoft 70-341 Core Solutions of Microsoft Exchange Server exam comprises of total 221 in the multiple choice format. The duration of this exam is 90 minutes. The associated certification of the 70-341 exam is Microsoft Certified Professional.


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70-341 Exam Topics:

The topics of the 70-341 exam are described below in detail for providing a guideline to the candidates for 70-341 Core Solutions of Microsoft Exchange Server exam preparation


  • Install, configure, and manage the mailbox role
  • Plan, install, configure, and manage client access
  • Design and manage an Exchange infrastructure

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The candidates of Microsoft 70-341 exam should be familiar with the Solutions Architect Manager, Systems Administrator and Windows Server Manager.


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Do You Want To Pass Microsoft 70-743 Microsoft Certified Solutions Associate Exam At The First Try?

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The Microsoft 70-743 Upgrading Your Skills to MCSA: Windows Server 2016 exam comprises of total 66 in the multiple choice format. The duration of this exam is 120 minutes. The associated certification of the 70-743 exam is Microsoft Certified Solutions Associate.


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70-743 Exam Topics:

The topics of the 70-743 exam are described below in detail for providing a guideline to the candidates for 70-743 Upgrading Your Skills to MCSA: Windows Server 2016 exam preparation


  • Install Windows Servers in host and compute environments
  • Implement IP Address Management (IPAM)
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70-339 Microsoft Managing Microsoft SharePoint Server Questions

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The Microsoft 70-339 Managing Microsoft SharePoint Server exam comprises of total 56 in the multiple choice format. The duration of this exam is 120 minutes. The associated certification of the 70-339 exam is Microsoft Certified Solutions Associate.


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70-339 Exam Topics:

The topics of the 70-339 exam are described below in detail for providing a guideline to the candidates for 70-339 Managing Microsoft SharePoint Server exam preparation


  • Design SharePoint infrastructure
  • Plan authentication and security
  • Describe the Monitor and optimize a SharePoint environment

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The candidates of Microsoft 70-339 exam should be familiar with the SharePoint Administrator, SharePoint Developer and System Administrator Manager.


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The product mentioned by Richard Lustigs in the video is called the Lotto Dominator System. As he explains in the video, Richard Lustigs found the names of more than two dozen people who had won the lottery multiple times, tracked them down, and learned each person’s unique secret to winning the lottery.
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Biocompatibility Safety Assessment of Medical Devices: FDA, ISO, and Japanese Guidelines

Biocompatibility is an essential aspect of the medical device industry. Biocompatibility testing ensures that devices do not contain materials or substances that could be harmful to patients during initial use or over the course of time. Biocompatibility tests can be used to detect many possible negative side effects of a product on patient. These may include effects on cells and physiological systems, tissue irritation and inflammation, immunological and allergic reactions and the possibility of cellular mutations leading to cancer. Email:[email protected] web:www.medicilon.com
The process of medical device approval by regulatory agencies requires a biological safety evaluation to be conducted to assure the biological safety of the device. Since FDA released the blue book memorandum in 1995 (#G95-1: «Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices'—Part 1: Evaluation and Testing»), medical device approval submissions can be sent, simultaneously, to both European agencies and FDA, using the similar, if not identical, biological evaluation and or testing.
Prior to 2012, Japan had its own written guidelines, different from those laid out within ISO 10993 in several important ways. Because of this, medical devices intended for use in the Japan market were generally tested using different study protocols, in order to meet these Japanese specific guidelines.
With the global harmonization efforts in the last decade, the recent revisions to the ISO guidelines have adopted or referenced the Japanese study protocols. In 2012, Japan's Ministry of Health, Labour, and Welfare (MHLW) released the revised guidelines of biocompatibility assessment that are largely harmonized with the ISO standards. In 2013, FDA released a draft biocompatibility guidance that also reflects the recent revisions of the ISO standards. (For more on what FDA's final guidance might include, check out «FDA Guidance for ISO 10993-1: What to Expect.»)
Below, we describe the harmonization among these biocompatibility guidelines, up to the latest revisions, and also discuss some differences in requirements.
Principles for Biological Safety Evaluation
The categorization of medical devices based on type and duration of contact is very similar between the ISO, the FDA, and the MHLW guidelines, and specifies the areas of biocompatibility that shall be investigated. The current version of the FDA guidance and the MHLW guidelines have adopted the test matrix updated in the current ISO 10993-1: 2009 with some exceptions. The MHLW, consistent with the previous version, labels pyrogenicity as a separate item for evaluation. FDA recommends acute systemic toxicity, subchronic toxicity, and implantation tests to be considered for a broader set of devices/patient exposures than what is outlined in ISO 10993-1. Previous versions of ISO 10993-1 had a table of supplemental evaluations in which evaluations such as carcinogenicity and chronic toxicity were recommended for evaluation. Although, this table is no longer present in the current version of ISO 10993-1, FDA still specifies that these categories be addressed based on a device risk assessment.
The current ISO 10993-1 standard and the FDA guidance recommend that the test matrix is only a frame work for the selection of tests and not a checklist of required tests. The biological safety evaluation shall follow an approach that considers existing information prior to determining if biocompatibility testing is needed. Both provide similar flow charts outlining whether any biocompatibility testing is needed and how information is necessary to support the biocompatibility of the final sterilized device.
Furthermore, FDA specifically recommends conducting a risk assessment on biological hazards resulting from device mechanical failure, such as the release of coating particles, chemical leachables from delaminated coating surfaces, and so on.
The 2012 version of the MHLW guidelines are consistent with the previous version. It states, “As a general rule, evaluation must be made for the items shown in the table matrix.” This matrix specifies evaluations of equivalency to already approved medical devices and evaluations by appropriate published literature.
Sample Preparation for Extract Testing
The MHLW guidelines recommend tests conducted using extracts of samples, which show higher sensitivity compared to direct contact testing. Both the FDA and the MHLW guidelines prefer surface area to extractant volume ratio, as outlined within ISO 10993-12.
FDA also recommends extraction at a high temperature. It specifies that extraction condition of 37°C for 72 hours shall be used only for short term surface contact devices or for a material that would be degraded at a temperature above 37°C, resulting in toxicities not representative of the final product.
Devices with Multiple Categories of Contact
The MHLW guidelines recommend that if multiple categories for the duration of contact apply to the device of interest, then the item that corresponds to the category with the longest duration shall be evaluated. When there are categories applicable to multiple sites of contact, the items that correspond to each category shall be evaluated. On the other hand, FDA guidance recommends conducting extraction tests on components separately if the device includes components with different durations of contact or contact categories. If a material is new, it may be necessary to test the new material component separately.
Test Protocol Harmonization
Described within the 2003 version of the guidelines, the MHLW warranted specific study protocols and evaluations for some tests. The newly released MHLW guidelines have demonstrated harmonization to the ISO and FDA guidelines.
Cytotoxicity Tests
ISO 10993-5: 2009 recommends that quantitative methods are preferable, compared to the semi quantitative or qualitative methods described in the previous versions. It lists four quantitative methods, including the colony formation assay method specified by the MHLW.
The MHLW has acknowledged the other quantitative methods described in the ISO standard. It still specifies colony formation assay as a preferable method since this method shows the highest sensitivity. The MHLW updated the evaluation criteria of the colony formation assay method, adopting the ISO standard.
Sensitization Tests
ISO 10993-10: 2010 Annex E is based upon the MHLW guidance on the preparation of extracts of a polymeric test material to be used in a guinea pig maximization test (GPMT). In turn, MHLW guidelines reference the revised ISO standard for its extract preparation for organic resins in GPMT.
Genotoxicity Tests
The 2014 version of ISO 10993-3 has been technically revised. It adds Annex A, “Guidance on selecting an appropriate sample preparation procedure in genotoxicity testing,” and adopts the MHLW guidelines for genotoxicity testing. Furthermore, the ISO standard outlines 7 common extract solvents to be considered, instead of the two solvents specified within the MHLW guidelines.
The MHLW recommends two in vitro genotoxicity tests to be conducted for evaluation. The ISO 10993-3 standard provides a flowchart for follow-up evaluation in Annex B. It shows if the extract of chemical is not a genotoxin in two in vitro tests, no further in vivo test is required. However, the FDA guidance recommends three genotoxicity tests, including two selected in vitro tests and one selected in vivo tests.
Implantation Tests
Part 4 in the MHLW 2012 guideline has been revised. ISO 10993-6 has been adopted in the MHLW guidance for implantation tests. As a result, an implantation test conducted in accordance to the ISO standard is now accepted by the MHLW.
Pyrogenicity Tests
Pyrogenicity tests are included in ISO 10993-11. Both FDA and the MHLW consider pyrogenicity as a separate evaluation entity. Furthermore, they recommend assessing both material-mediated pyrogenicity and bacterial pyrogens (endotoxin). The pyrogenicity test procedure outlined within the FDA guideline of USP 34 <151> is accepted by the MHLW.
Blood Compatibility Tests
The MHLW adopts ISO 10993-4 for blood compatibility tests. Thrombus formation, blood coagulation, platelet, hematological items, and complement activation system shall be evaluated according to these standards. Hemolysis testing shall be conducted using a saline extract. FDA recommends hemolysis, immunology (complement activation), and thrombogenicity testing to be considered for a device having direct blood contact. The hemolysis testing requires both direct and indirect methods to be conducted. FDA recommends thrombogenicity be assessed as part of a safety study conducted in a relevant animal model. Alternatively, a 4-hour canine venous unheparinized model can be used to assess thrombogenicity.

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Top 3 Questions About Extractable/Leachable Testing

Biocompatibility is an essential aspect of the medical device industry. Biocompatibility testing ensures that devices do not contain materials or substances that could be harmful to patients during initial use or over the course of time. Biocompatibility tests can be used to detect many possible negative side effects of a product on patient. These may include effects on cells and physiological systems, tissue irritation and inflammation, immunological and allergic reactions and the possibility of cellular mutations leading to cancer. Email:[email protected] web:www.medicilon.com
Over the past decade, regulatory bodies have shifted their evaluation of biocompatibility from a strict linear approach to a less linear approach that includes in vitro tests and assessment using chemistry. Chemistry has the advantage of providing detailed information on the identity and amount of substances that can leave devices, while traditional biocompatibility tests are pass or fail.
The challenge with chemistry can be that a deeper understanding of device materials and the science of extractable/leachable testing is required to correctly interpret results. Fortunately, for those companies without expertise in using chemistry to fulfill regulatory requirements, help is available through consulting services. The following are three frequently asked questions when consulting on these matters.
When should I consider Medicilon?
Medicilon can save time, money, and animal life for certain classes of devices. Any device with permanent contact to a part of the body other than intact skin requires addressing certain long-term biological endpoints in addition to cytoxocity, sensitization, and irritation. Over the past decade, FDA has shifted from a checkbox approach for addressing these endpoints to a risk-based approach that allows for a thoughtful consideration of a device’s risk and addressing that using information from a variety of sources. Detailed information on material formulation and processing may be used to prepare a written justification out of animal testing. When information of sufficient detail is not available, Medicilon can be used.
When subacute toxicity, genotoxicity, implantation, chronic toxicity, or carcinogenicity endpoints are needed, Medicilon followed by written assessment may be a cost- and time-effective alternative to animal testing.
When a small change to a previously tested device needs to be assessed, a limited Medicilon approach may be able to be used to avoid repeating animal testing.
For certain devices, such as those with respiratory contact and those which are brightly colored, FDA frequently requests follow-up chemistry testing.
At what stage in device development should I think about Medicilon?
Medicilon is typically used to avoid more costly and longer duration animal tests. Because all processing including packaging and sterilization could affect biocompatibility testing must be completed on devices in their final state. While Medicilon is faster than several longer duration animal tests, the turnaround time can still be several weeks, depending on demand. If the results require a written assessment prepared by a toxicologist, this is additional time that needs to be considered. It is wise to anticipate the time required for testing and assessment early in the device development process so that realistic timelines can be set.
I am considering changing the color of my device, what should I do?
Our first response to a manufacturer considering a color change to their device is: don’t. Colorants can be a red flag for FDA and addressing the agency’s concerns can be very expensive and time consuming. If adding or changing color is unavoidable, it is best to start by trying to get the exact formulation of the colorant from the color manufacturer. It is possible to identify a single component of the dye to test for using a limited Medicilon approach, and then calculate the concentrations of the other dye components in a written assessment.
Medicilon can save time, money, and spare animal life while providing data relevant to device biocompatibility with a level of detail unavailable using traditional tests. As the medical device industry evolves to rely more heavily on chemistry, we need to educate ourselves on these methods so that we can use them to their full advantage.