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EMC DES-3611 : Specialist - Technology Architect, Data Protection Exam

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Test Number : DES-3611
Test Name : Specialist - Technology Architect, Data Protection
Vendor Name : EMC
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DES-3611 test Format | DES-3611 Course Contents | DES-3611 Course Outline | DES-3611 test Syllabus | DES-3611 test Objectives

Exam Title : Dell EMC Certified Specialist - Technology Architect - Data Protection
Exam ID : DES-3611
Exam Duration : 120 mins
Questions in test : 65
Passing Score : 60%
Official Training : Data Domain Fundamentals (MR-1WP-DDFUND)
Integrated Data Protection Appliance Fundamentals (MR-1WN-IDPAFUN)
NetWorker Fundamentals (MR-1WP-NWFUN)
Exam Center : Pearson VUE
Real Questions : Dell EMC Data Protection Specialist Technology Architect Real Questions
VCE practice questions : Dell EMC DES-3611 Certification VCE Practice Test

Dell EMC Data Protection Product Features, Functions, Software-based

Architectures and/or Components (31%)
Identify and describe the available tools and services to assess a customer's environment for a data protection solution
Describe the Dell EMC Cloud Data Protection Solutions features, functions, and/or architecture/components
Describe the Dell EMC Data Domain features, functions, and/or architecture/components
Describe the Dell EMC NetWorker features, functions, and/or architecture/components
Describe the Dell EMC RecoverPoint and RecoverPoint for Virtual Machines (VMs) features, functions, and/or architecture/components
Describe the Dell EMC Integrated Data Protection Appliances (IDPA) features, functions, and/or architecture/components
Describe the Dell EMC Data Protection Suite for Applications (DPS) features, functions, and/or architecture/components
Describe the Dell EMC Isolated Recovery Solutions features, functions, and/or architecture/components

Dell EMC Data Domain Solutions Design (8%)
Identify and describe the best practices for capacity planning, performance tuning, sizing, and designing a Dell EMC Data Domain data protection solution

Dell EMC NetWorker Solutions Design (8%)
Explain Dell EMC NetWorker capacity planning and performance tuning
Identify and describe the best practices for sizing and designing a Dell EMC NetWorker data protection solution

Dell EMC Avamar Solutions Design (7%)
Explain Dell EMC Avamar capacity planning and performance tuning for a data protection solution
Identify and describe the features, functions, and the best practices for sizing and designing a Dell EMC Avamar data protection solution Dell EMC RecoverPoint and RecoverPoint for Virtual Machines (VMs) Solutions

Design (17%)
Explain the replication concepts and replication planning for a Dell EMC RecoverPoint and Dell EMC RecoverPoint for VMs data protection solution
Explain Dell EMC RecoverPoint and Dell EMC RecoverPoint for VMs capacity planning for a data protection solution
Identify and describe the best practices for designing a Dell EMC RecoverPoint and Dell EMC RecoverPoint for VMs data protection solution

Dell EMC Cloud Data Protection Solutions Design (8%)
Explain Dell EMC Cloud Data Protection capacity planning and performance tuning for a data protection solution
Identify and describe the best practices for sizing and designing a Dell EMC Cloud Data Protection solution

Dell EMC Integrated Data Protection Appliances (IDPA) Solutions Design (9%)
Explain Dell EMC Integrated Data Protection Appliances (IDPA) deployment planning and performance tuning
Identify and describe the best practices for sizing and designing a Dell EMC Integrated Data Protection Appliances (IDPA) solution

Dell EMC Data Protection Suite for Applications (DPS) Solutions Design (6%)
Identify and describe Dell EMC Data Protection Suite for Applications (DPS) integration planning considerations and best practices

Solutions Design using Dell EMC Isolated Recovery Solutions Design (6%)
Identify and describe Dell EMC Isolated Recovery Solutions licensing, design considerations, and best practices for a data protection solution
The percentages after each subject above reflects the approximate distribution of the total question set across the exam

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EMC Practice Test

Design for Regulatory Compliance | DES-3611 genuine Questions and test Questions

while working for Hewlett-Packard’s scientific neighborhood, a manager stated, “When the boundaries to entry are high, people who overcome them have a strategic skills.” That adage has remained crucial within the context of the ever-altering regulatory strategies that are a vital part of bringing a new clinical gadget to market.

there was a great deal debate and consternation, primarily these days, concerning the 510(k) technique, and there will undoubtedly be alterations going ahead. this text proposes a basic shift within the philosophy of how regulatory methods might have interaction with the product building manner and paradigm to provide enhanced efficiency and more predictable results, inspite of how regulations evolve sooner or later.

As a product dressmaker, it's often more straightforward to criticize the technique than to figure out how to make it work to your capabilities. youngsters, there are steps that will also be taken all through the product design phase to make the regulatory method extra helpful. Design for regulatory can become a strategic talents. this text discusses what design for regulatory’ entails and what it will mean to include regulatory pondering into the design system.

The Regulatory ChallengeWhat does design for regulatory imply? it is a system identical to those presently in follow:

  • Design for reliability.
  • Design for manufacturability.
  • Design for electromagnetic compatibility (EMC).
  • Design for testability.
  • each and every of those paradigms brings the area skills of what is regarded a downstream product building pastime into the early design method. The purpose is to get rid of surprises late within the product development technique that often produce negative outcomes similar to expensive reworks, overlooked milestones, and ultimately delays in market introduction and revenue.

    So how will they beginning? the primary thing to do is to google “design for regulatory.” You’ll locate broadly speaking bits of slim work on EMC and wireless design, and the web sites of a couple of regulatory affairs consulting companies. There are very few online search hits on a way to introduce regulatory concerns into product design and even much less suggestions about that procedure for medical product design.

    Let’s start by using figuring out the desires of the regulatory approaches. In accepted, they exist to ensure that secure and positive items are delivered into the market region with acceptable possibility-benefit ratios. every manufacturer, clothier, regulatory skilled, clinical practitioner, and purchaser has this as a common intention. despite the fact, if this is the case, why are there at all times considerations?  The considerations originate within the approach regulatory compliance is treated right through the development method. it's commonly considered as an afterthought or a imperative evil to be demonstrated for and often gamed on the end of the technique when bad regulatory comments is awfully frustrating and high priced. Even one request for more information may also be devastating to a corporation’s plans and financial well-being. Funding for birth-united states of americaand small businesses is frequently tied to regulatory milestones.1

    Some businesses take dangers, purposely or no longer, through attempting to do the minimal required or cautiously crafting claims in the hope of getting past FDA. despite the fact these suggestions may occasionally work, obviously they do not lead to predictable success, because they can lead frustrate or anger reviewers. A perceived stream towards a greater risk-averse FDA make this method much less more likely to produce a successful result.

    So what are you able to do? With latest ‘design for …’ strategies, teams encompass the stakeholders who make sure successful execution of the plans. similarly, organizations can comprise regulatory affairs gurus (or these with extensive regulatory adventure) without delay into their design groups to make certain that the regulatory issues and necessities are addressed in planning and subsequent design phases. This approach encourages the crew participants to use their experience and competencies to design items and test programs if you want to allow the introduction of regulatory-in a position products.

    The crew can additionally acquire the records and evaluation to guide easy submissions and hopefully clearance and with any first rate multistep reform system, the 1st step is to confess that there is a problem and agree that the organization desires to solve it. however regulatory development is complicated to tune except a product is near the end of the construction system, the supplies to achieve this either exist already in corporations or can be identified and assigned (or shrunk) tasks early in the project. Any costs thinking are limited to the fundamental regulatory components. There are tremendous rate reductions to be received from limiting redesign, additional exams, rounds of regulatory evaluate, and delayed income.

    meant Use and signs for UseThe most vital product facets to agree upon in the beginning of the building method are intended use and signals for use. however the genuine definition of these terms (other than what is equipped in 21 CFR 801.four) is at present under discussion at FDA and may evolve, they nearly discuss with what the machine will do and the way it could be used.organizations regularly get to the conclusion of product building and have heated inner discussions with designers, marketers, and regulatory agencies, discovering that the facets and claims made in submissions do not help the marketing substances. The method of making changes and realigning messaging is expensive and totally disruptive to a firm. Having a clear dialogue and agreement, in addition to forming a written documentation up entrance that including supposed use, signals to be used, and claims, will add consistency and predictability. The claims form the starting aspect for submission applications, deliver necessities, and drive necessities within the product design. Verification and validation checking out and collateral materials, akin to person documentation and marketing substances, develop into neatly aligned with claims from the beginning of the procedure.

    necessities and suggestions DocumentsIndustry specifications should be used and referenced at any place it's acceptable. necessities will also be a sensitive area in the aggressive market, but they're primary for evaluating and evaluating performance. agencies similar to AAMI have proven that necessities can also be with ease developed in an open and nonthreatening discussion board and include all events concerned.

    specifications allow organizations to correctly evaluate conformance and dangle each gadget to a minimum stage of performance. standards do not stifle innovation however as an alternative channel it towards exceeding efficiency and decreasing expenses through concentrating company efforts. They also enable direct head-to-head comparisons in the market between aggressive items.

    When a design crew uses standards and advice documents as design enter, the documents should still provide the minimal requirements. Exceeding the standards can have market advantages if doing so outcomes in demonstrable merits. as an example, IEC 60601-1-eleven requires an working temperature range of 5°–40°C for transit operable domestic healthcare clinical machine. although, there are lots of use environments  use wherein this specification may well be handed—Fairbanks, AK has a typical low temperature of -28°C in January and Phoenix, AZ has an ordinary high temperature of above forty one°C in July.

    Designing and checking out to a larger latitude can allow marketing claims of operation in much less restrictive environments and will yield client benefits or fewer provider and equipment failure issues. These benefits must be supported with appropriate proof as required by using the regulatory procedure.

    When there are multiple requisites, reminiscent of foreign company necessities, the regulatory and design services deserve to work together to choose the superset for the product requirements to enable clean introduction into further markets.

    counsel files from regulatory agencies don't seem to be standards in the literal feel, but should still be treated as standards and their options included as design input. not taking information files seriously or assuming that they aren't relevant to a product is a typical and unlucky mistake. If an organization elects now not to follow an accessible counsel or uses most effective portions that it considers relevant, it can advance and support that justification determination early in the design method. furthermore, every person on the group should be at ease with the resolution, whereas the results of testing to guide the choice may still be included into the early regulatory submission drafts.

    Don’t forget to review draft guidances and look for prepublication drafts that can also supply insight into changing company expectations. besides the fact that children these drafts may also nonetheless be open for comments or no longer yet finalized, they could provide constructive insight into FDA’s existing pondering in a specific enviornment. The company has been established to implement draft suggestions. Paying attention to those expectations early on saves time and labor later within the method considering drafts early in a product development cycle regularly become defacto necessities or are integrated into necessities by the time the product is in a position for submission.

    Have a Regulatory StrategyOnce the machine use and requirements are understood, it's time to work on the regulatory method. Early within the design system, talk about and consist of right here key objects: 

  • Proposed claims.
  • Preliminary instructions for use.
  • Predicate equipment decisions. it's also sensible to attain the predicate gadget’s 510(k) filings through Freedom of assistance Act requests.
  • device classification—type I, II, or III; exempt; 510(k); or do the claims aspect against a PMA?
  • overseas advertising approach and further regulatory company necessities: CE, health Canada, Federal Communications fee, medical insurance Portability and Accountability Act of 1996.
  • Packaging wants and labeling requirements, together with overseas symbols and warnings.
  • comparison checking out, including bench and medical testing that is needed to assist vast equivalence.
  • test plan to exhibit conformance to latest standards.variations between predicates and standards, and the way the differences (if any) could be represented and supported.
  • 513(g) (request for clinical machine classification) or preinvestigational equipment exemption (IDE) conferences with FDA to help support the strategic regulatory course.
  • the usage of off-the-shelf add-ons or expertise to be sure their defense and effectiveness with the machine.
  • repayment strategy and requirements for aiding statistics—this may additionally power claims and appreciably trade the strategic product center of attention. while now not the focus of this article, it is a crucial part of the marketing strategy for any clinical product or carrier. Create a parallel evaluate procedure to make insurance determinations whereas FDA clearance or approval is below dialogue.
  • These are extraordinarily critical discussions and decisions, and it is quintessential that they be correctly documented. The discussions and components evaluated that ultimately pressure the decisions are only as critical to helping the decisions stick and conserving the challenge from disruptive reanalysis procedures.

    The discussions may additionally carry up sizeable issues and create an opportunity to alter the design of the product to unravel regulatory considerations. Designers should no longer panic or  are trying to video game the gadget. Most commonly, a corporation will lose with a strategy that tries to get around regulatory issues or obscure them.

    consider considerations rationally. They may also cause changes that will also be helpful for the customer or create a chance to elevate the bar with FDA. as an example, the potential to bring together additional equipment facts all the way through use can enable extra markets if correctly designated and applied. These sorts of features can also also be used construction testing and box carrier.comparison trying out and statistics assortment can not be overemphasized. a company can create a submission that offers it an talents over rivals via including unbelievable comparative records beyond that which turned into supplied in past submissions. These equal facts can then be used for marketing applications, making it tricky and expensive for opponents to reply once the product is added into the market and lengthening the hurdles they’ll face when submitting statistics for a future product.

    believe the pre-IDE meeting and current your design for regulatory compliance case to FDA. helping the agency remember that the gadget is designed to be a proactive a part of the regulatory manner can help the company benefit support from the community that can be reviewing the submission. The pre-IDE meeting is constructive for opting for concerns and setting up allies at FDA.

    prepare Submission documents during Product DesignOnce the enter necessities and product standards are comprehensive, the design group can have plenty of the advice that it needs to create regulatory submissions for all international locations within the business plan. besides the fact that children the check statistics are lacking, the tables may also be created proforma to be crammed in with the acceptable passing verification and validation facts as these tests are completed.

    All too frequently, these files are prepared a whole lot later within the procedure. it's more convenient and cheaper to make changes early in the process. Regulatory changes are not any different, except that during the past, companies have hardly ever regarded altering products to facilitate more straightforward and extra comprehensive regulatory approvals. as an alternative, they alter product claims and restrict the market skills for his or her equipment. in the long run, this method is more expensive.creating these documents early permits a corporation to determine and repair deficiencies pretty without difficulty and at not pricey. Early advent of those files can also also alter the regulatory strategy.

    Hazard AnalysisSurprises in the regulatory system can often be traced back to hazard evaluation. For the functions of this text, the term hazard analysis is used as a broad category to include failure modes and effects analysis and all other appropriate possibility and hazard evaluation strategies as applicable to medical gadgets.

    concerns always arise from the omission of risks linked to new applied sciences (reminiscent of replacing a cable the use of instant expertise) or unrealistic scoring of the hazard or its mitigation. whether this consequences from a lack of appreciation for brand spanking new risks or unquestioning reuse of the analysis from the old product era, omitting them can result in big issues.

    This evaluation offers one more possibility to design for regulatory as it offers additional enter necessities. Product design changes probably supply the strongest mitigations and are every so often the inexpensive. Design changes early within the technique are much lower priced and time-consuming than creation tweaks. facets may also be added to deliver extra safety or robustness to facts, and further aspects can assist in verification for different mitigation initiatives that can also no longer be latest within the core product points and requirements.

    good information for hazard analysis is supplied in ISO 14971, and it's always very constructive to cautiously evaluation the analysis of predicate gadgets.

    preserving and Patenting facets for CompliancePay selected attention to any elements introduced to a product to facilitate the regulatory submission, such as those allowing for data assortment right through verification or validation testing, or these mitigating hazards. evaluation of these aspects and their implementation might find patentable material and as soon as once again, aggressive merits. Patents do not should be flashy to be constructive in making it problematic for a competitor to execute its regulatory method. accept as true with any function that has been delivered as a result of the regulatory overview or a special design factor that makes it possible for simpler demonstration of safeguard or efficacy for insurance policy.

    Design the examine ProgramCreating the regulatory plan and prototype submission early makes it possible for some creativity in combining points to make the top-rated testing program. as an example, during the setup trying out part for a brand new product, checking out of predicate and aggressive products may also be carried out with minimal further work and cost. it's effective to know how the competition performs not handiest for the regulatory submission, but additionally for product advertising and marketing purposes. If a key product performance outcome can be identified and supported in its price to the product or for the client, FDA could recognize it as a requirement for future products submitted with the aid of competitors.

    extremely accelerated lifestyles checking out and enormously accelerated stress screening checking out are staggering strategies. however, do not underestimate the value of checking out the boundaries during standard performance checking out.

    A check program will regularly adhere to the inner and advertised requirements to set check limits. This suggestions is primary for submissions, but whereas a look at various is install, it can be very helpful to continue the testing to set up design margins and potentially beneficial characterization tips. This counsel can aid show the robustness of a design and may permit for an elevated warranty to the client or decrease accumulated warranty charge expectations.test screw ups are inevitable. Fixing considerations which are recognized all over validation or verification actions gives another chance to trust the large photo and encompass regulatory considerations.

    although EMC has obtained attention from the agency (together with institution of a relationship with the FCC), don’t forget that it's additionally an issue for the customer. EMC testing of competitive products can yield an knowing of competencies interactions in addition to their product weaknesses. it will permit design changes that make products extra compatible and support the client with advantageous installing and operation suggestions. It may also potentially provide sales and advertising departments effective aggressive facts.

    Design teams and FDA SubmissionThe designers have entertaining perception into the product and its technology. it is an competencies to make use of this abilities in drafting particular sections of the submission, technology descriptions, and comparisons. seeing that the whole crew has been concerned in the procedure, all and sundry could be proactive and engaged. There is generally sections of the submission that can be reused directly from product design files, because they  contain supporting material reminiscent of drawings.

    Reviewers Are Your FriendsFinally, the reviewer is your chum; the design crew may still agree with this remark too. Make it a main purpose to your reviewer(s). they have got a huge workload that incorporates many different items and can not have the depth of capabilities and capabilities to wholly respect your product. feel about helping a friend consider this high-quality new product and you’ll have a more robust submission.

    education is even more critical if this product introduces a new know-how or approach. Don’t assume that as soon as it seems on Wikipedia your reviewer may be an expert. once here's dependent as an operating principle, respectable things can take place. people will believe about how to make the reviewer’s job more straightforward by means of providing magnificent facts and supporting cloth. Any new or complex ideas might be accompanied by means of extraordinary industry and peer-reviewed reference cloth. Reviewer-friendly submissions will assist you profit allies at FDA.

    ConclusionDesign for regulatory is a valuable conception, despite future changes to agency requirements or processes. different ‘design for…’ paradigms have proven that up-entrance, early consideration of tasks which are usually performed at the end of the product construction method reduces time to market and charges associated with redecorate.however following the information in this article is not with out can charge, doing so is a rewarding funding. The building of a solid regulatory method and the incorporation of regulatory components into the design method will make sure fewer surprises and enable for more productive and potentially less difficult FDA submissions. This paradigm can also yield better aggressive information and product positioning and potentially create a aggressive advantage within the marketplace.

    Reference1. Conroy S, “reduced VC money potential New Challenges for Medtech birth-Ups,” MD+DI 32, no. 10 (2010): 18; obtainable from information superhighway:

    bill Saltzstein is founder of Code Blue Communications Inc. (Woodinville, WA). 

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