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| − | {| style="background-color:#3f2a56; width: 80%; color:white; float:left;"
| + | '''This tool is intended to assist you with the classification of your medical device''' by walking through the classification rules found in Schedule 1 of the ''[https://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/FullText.html Medical Devices Regulations]''. |
| − | ![[#Team|<big><div id="Team"><span style="color:#ffffff">Surge at the School</span></big>]]
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| − | !<big>[[#Delivering results for the GC since 2018|<span style="color:#ffffff">Delivering results for the GC since 2018</span>]]</big>
| + | It is only intended to classify products that meet the definition of a “device” in the ''[https://laws-lois.justice.gc.ca/eng/acts/f-27/FullText.html Food and Drugs Act]'' and a “medical device” into Class I, II, III or IV. |
| − | !<big>[[#An extension of your team|<span style="color:#ffffff">An extension of your team</span>]]</big>
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| − | !<big>[[#Why work with us|<span style="color:#ffffff">Why work with us</span>]]</big>
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| − | !<big>[[#How we can help|<span style="color:#ffffff">How we can help</span>]]</big>
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| − | !<big>[[#Our partnership model|<span style="color:#ffffff">Our partnership model</span>]]</big>
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| − | !<big>[[#Testimonials|<span style="color:#ffffff">Testimonials</span>]]</big>
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| − | !<big>[[#For more information, contact us|<span style="color:#ffffff">For more information, contact us</span>]]</big>
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| − | |}
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| | | | |
| − | __NOTOC__
| + | It will **not** determine whether your product is *not* a medical device or if it falls under another category (e.g., drug, consumer product). |
| | + | Users must confirm that their product meets the definition of a “medical device” before proceeding. |
| | | | |
| − | __NOTOC__
| + | ---- |
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| − | <big><big>'''For best results please view this page on a desktop browser'''</big></big><br>
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| − | <big><big>'''Pour la version française, [https://wiki.gccollab.ca/Equipe_de_renfort cliquez ici]'''</big></big>
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| | | | |
| − | =='''<big><big><big>Surge at the School</big></big></big>'''==
| + | <div style="text-align:center;"> |
| − | <big><big>The Surge team helps organizations achieve their priorities. Our position within the School provides us with a neutral, bird’s-eye view across government; enabling us to work with any organization, on any file, to get results.</big>
| + | '<nowiki/>'''''Click below to launch the Classification Tool'''''' |
| − | {| width="90%" cellpadding="10" cellspacing="15px"
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| − | |style=background:#c6d4e8|<big>Surge is the '''hands-on''' application of the School’s mandate to strengthen capacity and promote excellence in the public service. </big>
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| − | |}
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| − | <big>We embed directly into your work to tackle your priority initiatives. Our approach has two key benefits:</big>
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| − | |style=background:#c6d4e8|[[File:People_picture.svg|center|frameless|upright=0.5]]
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| − | |style=background:#ecf1f7|<big>'''For your team''': We deliver successful project outcomes while enhancing your team's capabilities</big>
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| − | |style=background:#c6d4e8|[[File:For us Picture.png|center|frameless|upright=0.5]]
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| − | |style=background:#ecf1f7|<big>'''For us''': We gain firsthand insights into public servants' experiences to support '''relevant, practical, and effective training'''</big>
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| − | |}
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| − | | |
| − | ==<div id="Delivering results for the GC since 2018"><big><big>'''Delivering results for the GC since 2018'''</big></big> ==
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| − | <big>Since December 2018, we have worked with 15+ GC organizations and teams to deliver '''+60 projects''' with '''+150 deliverables''' and have received '''overwhelmingly positive feedback''' by:</big>
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| − | |style=text-align:center;background:#3f6281;color:#FFFFFF|<big>'''Modernizing legacy systems, legislation, and service delivery models'''</big>
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| − | |style=text-align:center;background:#365687;color:#FFFFFF|<big>'''Adding policy and strategic capacity'''</big>
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| − | |style=text-align:center;background:#457477;color:#FFFFFF|<big>'''Improving internal governance and simplifying processes'''</big>
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| − | |style=text-align:center;background:#24494a;color:#FFFFFF|<big>'''Targeted learning to respond to GC priorities'''</big>
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| − | |style="width:400px"|[[File:Modernizing legacy systems, legislation, and service delivery models Image1.png|alt=|center|frameless]]
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| − | |style="width:400px"|[[File:Adding policy and strategic capacity image1.png|alt=|center|frameless]]
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| − | |style="width:400px"|[[File:Improving internal governance and simplifying processes Image1.png|alt=|center|frameless]]
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| − | |style="width:400px"|[[File:Targeted learning to respond to GC priorities Image1.png|alt=|center|frameless|261x261px]]
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| − | <big>These projects have helped to advance learning, innovation, and policy priorities across the federal government.</big>
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| | + | [[File:Classification.png|link=https://forms.office.com/Pages/ResponsePage.aspx?id=FZD9Qk3eI0KjaLrqyrSJJyG_2PeVuVlHvSZss2grfWZUODlISFRJMVlUSzhISDgyWkEyWlUzMk1GMi4u|alt=Classification Tool|200px]] |
| | + | </div> |
| | | | |
| − | ==<div id="An extension of your team "><big><big>'''An extension of your team'''</big></big> ==
| + | ---- |
| − | <big>We are a '''diverse team of policy analysts''' ready to help '''advance your priorities'''; we jump into your work alongside your team and leverage our deep experience within the GC</big>
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| − | |style=text-align:center;background:#dde6ee|<big>'''Experience'''</big>
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| − | |style=text-align:center;background:#bbcdde|<big>'''Skillsets'''</big>
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| − | |style=text-align:center;background:#ddebeb|<big>'''Collaboration'''</big>
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| − | |style=text-align:left;background:#dde6ee|<big>We bring an '''impartial, cross-governmental perspective'''; our mandate allows us to build connections and work across government.
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| − | We use our experience in '''strategic policy, central agencies, program policy, and data teams''' to rapidly get up to speed on your operating environment.
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| − | We have almost '''a decade of experience''' creating presentations for ministerial and deputy-level audiences.'''</big>
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| − | |style=text-align:left;background:#bbcdde|
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| − | <big>We are a '''self-managed, self-organizing team''' ready to deploy at any time.
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| − | We are '''agile''': we develop, test, and continually iterate on our deliverables with our partners.
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| − | We are well-versed in '''how to use AI responsibly''' in the policy field.
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| − | We '''interpret and visualize data''' in a manner understandable to any audience.</big>
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| − | |style=text-align:left;background:#ddebeb|<big>We support with '''open collaboration''', a focus on '''relationship-building''', and '''adaptability''' to fulfill your needs.
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| − | '''We are fully committed to your team'''; each project team on Surge is dedicated to one project at a time.
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| − | We will ensure a '''smooth handover''' process at the end of the project and will be '''available to answer any questions.'''</big>
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| − | |}
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| − | <big>Using a cost-sharing model, the '''Surge Team offers departments additional support''' to tackle their complex problems.</big>
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| − | ==<div id="Why work with us">'''<big><big>Why work with us</big></big>'''==
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| − | <div style="display:inline-table">
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| − | {|width="90%" cellpadding="10" cellspacing="15px"
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| − | |style=text-align:center;background:#3f6281;color:#FFFFFF|<big>'''Short-term, inexpensive policy capacity'''</big>
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| − | |style=text-align:center;background:#365687;color:#FFFFFF|<big>'''Different skillsets, toolsets, and mindsets'''</big>
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| − | |style=text-align:left;background:#dde6ee|<big> '''Applicable when…'''
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| − | - You need policy capacity to achieve your priorities
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| − | - Long-term staffing commitments are difficult or not required
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| − | - Salary budget is limited but O&M dollars remain
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| − | </big>
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| − | |style=text-align:left;background:#ecf1f7|<big> '''When your team is rarely asked to engage in policy work, including:'''
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| − | - Briefing materials for senior officials
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| − | | |
| − | - Decision documents
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| − | - Engagement planning and facilitation
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| − | - Research, environmental scans, and data
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| − | - Internal restructuring or prioritization exercises
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| − | | |
| − | - Challenge function and outside perspective
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| − | </big>
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| − | |}
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| − | | |
| − | ==<div id="How we can help">'''<big><big>How we can help</big></big>'''==
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| − | <big>Our most commonly-used '''products and services''' are listed below, or tell us more about your specific needs; '''we specialize in developing custom-solutions for unique problems.'''</big>
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| − | | style="border-left: 10px solid #103768; box-shadow: 0 4px 8px 0 rgba(0, 0, 0, 0.2), 0 6px 15px 0 rgba(0, 0, 0, 0.19); color: black; background-color: white; font-size:1.0em;" |
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| − | {|
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| − | |style="width:100px"|[[File:RAS Image1.svg]]
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| − | |style="width:200px"|<big>'''Research, Analysis and Synthesis'''</big>
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| − | |<big>Data Collection & Gaps Analysis; Stakeholder & Process Mapping; Jurisdictional Reviews & Best Practice Research; Environmental Scans & Literature Reviews; Policy Reports</big>
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| − | |}
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| − | |}
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| − | {| width="70%" cellpadding="10" cellspacing="15px"
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| − | |- valign="top"
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| − | | style="border-left: 10px solid #5483ac; box-shadow: 0 4px 8px 0 rgba(0, 0, 0, 0.2), 0 6px 15px 0 rgba(0, 0, 0, 0.19); color: black; background-color: white; font-size:1.0em;" |
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| − | |style="width:100px"|[[File:HC Image1.svg]]
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| − | |style="width:200px"|<big>'''Horizontal Collaboration'''</big></big>
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| − | |<big>Internal Consultation Across Government; Facilitation (only within the GC), Interviews, Focus Groups & Surveys; Stakeholder Engagement Planning; Governance Model Design & Mapping; RACI Charts</big>
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| − | |}
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| − | |}
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| − | {| width="70%" cellpadding="15" cellspacing="15px"
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| − | |- valign="top"
| + | '''Please note:''' |
| − | | style="border-left: 10px solid #457477; box-shadow: 0 4px 8px 0 rgba(0, 0, 0, 0.2), 0 6px 15px 0 rgba(0, 0, 0, 0.19); color: black; background-color: white; font-size:1.0em;" |
| + | The tool provides classification guidance **based strictly on your inputs** and should **not** be taken as a final decision by Health Canada. |
| − | {|
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| − | |style="width:100px"|[[File:BC Image 1.svg]]
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| − | |style="width:200px"|<big>'''Briefing and Communication'''</big>
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| − | |<big>Briefing Materials for Senior Audiences; Reporting & Performance Dashboards; Memoranda to Cabinet, Treasury Board Submissions</big>
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| − | |}
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| − | |}
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| | | | |
| − | {| width="70%" cellpadding="15" cellspacing="15px"
| + | ---- |
| | | | |
| − | |- valign="top"
| + | ==Guidance Documents== |
| − | | style="border-left: 10px solid #85c2c4; box-shadow: 0 4px 8px 0 rgba(0, 0, 0, 0.2), 0 6px 15px 0 rgba(0, 0, 0, 0.19); color: black; background-color: white; font-size:1.0em;" |
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| − | {|
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| − | |style="width:100px"|[[File:Strategic Advice Image1.svg]]
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| − | |style="width:200px"|<big>'''Strategic Advice'''</big>
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| − | |<big>Policy Development & Options Analysis; Strategic Planning & Roadmapping; Performance Measurement Strategies (e.g., Logic Models, PIPs); Change Management</big>
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| − | |}
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| − | |}
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| | | | |
| − | {| width="70%" cellpadding="10" cellspacing="15px"
| + | '''The following documents provide definitions, examples, and additional information:''' |
| | | | |
| − | |- valign="top"
| + | *[https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-non-vitro-diagnostic.html Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices] |
| − | | style="border-left: 10px solid #bdd175; box-shadow: 0 4px 8px 0 rgba(0, 0, 0, 0.2), 0 6px 15px 0 rgba(0, 0, 0, 0.19); color: black; background-color: white; font-size:1.0em;" |
| + | *[https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-risk-based-classification-system-vitro.html Guidance for the Risk-based Classification System for In Vitro Diagnostic Devices] |
| − | {|
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| − | |style="width:100px"|[[File:CB Image 1.svg]]
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| − | |style="width:200px"|<big>'''Capacity Building'''</big>
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| − | |<big>Process Improvement & Implementation; Lessons Learned Facilitation; Reuseable Resources and Templates Development; Targeted Training (e.g., presentation design, navigating government processes) </big>
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| − | |}
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| − | |}
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| | | | |
| − | ==<div id="Our partnership model"><big><big>'''Our partnership model'''</big></big> ==
| + | '''''For Software as a Medical Device (SaMD):''''' |
| | | | |
| − | <big>Our mission is to help departments across the GC to achieve their priorities. Our model allows us to offer our services faster, at a lower cost, while providing high quality deliverables.</big>
| + | *[https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance-document.html SaMD: Definition and Classification] |
| − | | + | *[https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/software-medical-device-guidance/examples.html SaMD: Classification Examples] |
| − | <br clear="all">
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| − | |style="width:400px"|[[File:Lower costs Image4.png|alt=|center|frameless]]
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| − | |style="width:400px"|[[File:Fast to deploy image2.png|alt=|center|frameless]]
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| − | |style="width:400px"|[[File:You are in control image.png|alt=|center|frameless]]
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| − | |style="width:400px"|[[File:Expanded network image.png|alt=|center|frameless|261x261px]]
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| − | |style=text-align:center;background:#98b5cd|<big>'''Lower costs'''</big>
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| − | |style=text-align:center;background:#a0b7d9|<big>'''Fast to deploy'''</big>
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| − | |style=text-align:center;background:#abccce|<big>'''You are in control'''</big>
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| − | |style=text-align:center;background:#bdd175|<big>'''Expanded network'''</big>
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| − | |style=text-align:center;background:#dde6ee|<big> We charge '''85% of FTEs'''; providing access to dedicated team of analysts </big>
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| − | |style=text-align:center;background:#ecf1f7|<big> Compared to hiring term/indeterminate staff or consultants, '''we can start working with you in as little as 1- 2 weeks''' </big>
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| − | |style=text-align:center;background:#ddebeb|<big> We’ll contribute new ideas and perspectives, while '''you retain the final say''' </big>
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| − | |style=text-align:center;background:#e4ecc6|<big> You have access to our '''horizontal knowledge and connections''' </big>
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| − | |}
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| − | | |
| − | ==<div id="Testimonials"><big><big>'''Testimonials'''</big></big> ==
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| − | <div style="display:inline-table">
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| − | {| style="width:30em;" cellpadding="15" cellspacing="15px" height:30em
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| − | {|
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| − | |<big>"...the '''most concise, comprehensive, and visually appealing''' summary of Crown-Indigenous relations I've come across."</big> <br> ~ Environment and Climate Change Canada </big>
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| − | |}
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| − | |}
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| − | </div><div style="display:inline-table">
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| − | | style="border-left: 10px solid #9ad4d6; border-right: 10px solid #9ad4d6; box-shadow: 0 4px 8px 0 rgba(0, 0, 0, 0.2), 0 6px 15px 0 rgba(0, 0, 0, 0.19); color: black; background-color: white; font-size:1.0em;" |
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| − | {|
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| − | |<big>"Love the expertise you provided, with '''customized support''' to make this work easier."</big> <br> ~ Employment and Social Development Canada </big>
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| − | |}
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| − | |}
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| − | </div><div style="display:inline-table">
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| − | {| style="width:30em;" cellpadding="15" cellspacing="15px" height:30em;
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| − | | style="border-left: 10px solid #627dd0; border-right: 10px solid #627dd0; box-shadow: 0 4px 8px 0 rgba(0, 0, 0, 0.2), 0 6px 15px 0 rgba(0, 0, 0, 0.19); color: black; background-color: white; font-size:1.0em;" |
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| − | {|
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| − | |<big>"This is '''way better work''' than KPMG."</big> <br> ~ Natural Resources Canada </big>
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| − | |}
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| − | |}
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| − | </div><div style="display:inline-table">
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| − | | style="border-left: 10px solid #433f78; border-right: 10px solid #433f78; box-shadow: 0 4px 8px 0 rgba(0, 0, 0, 0.2), 0 6px 15px 0 rgba(0, 0, 0, 0.19); color: black; background-color: white; font-size:1.0em;" |
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| − | {|
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| − | |<big>"'''This is very good work''', especially given how little you've been given to work with."</big> <br> ~ Department of National Defence </big>
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| − | |}
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| − | |}
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| − | </div><div style="display:inline-table">
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| − | | style="border-left: 10px solid #3b305A; border-right: 10px solid #3b305A; box-shadow: 0 4px 8px 0 rgba(0, 0, 0, 0.2), 0 6px 15px 0 rgba(0, 0, 0, 0.19); color: black; background-color: white; font-size:1.0em;" |
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| − | {|
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| − | |<big>"There are a few [exercises] that have stood out over the course of my career, and this is '''one of the high flyers'''."</big> <br> ~ Employment and Social Development Canada </big>
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| − | |}
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| − | |}
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| − | </div><div style="display:inline-table">
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| − | | style="border-left: 10px solid #bdd175; border-right: 10px solid #bdd175; box-shadow: 0 4px 8px 0 rgba(0, 0, 0, 0.2), 0 6px 15px 0 rgba(0, 0, 0, 0.19); color: black; background-color: white; font-size:1.0em;" |
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| − | {|
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| − | |<big>"The team [has] provided us excellent support and have shown creativity and a '''high capacity to integrate concepts and show discernment'''. And the outcomes have benefited from our collaboration tremendously with our storytelling becoming clear, engaging, and compelling."</big><br> ~ Public Services and Procurement Canada </big><br>
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| − | | style="border-left: 10px solid #9ad4d6; border-right: 10px solid #9ad4d6; box-shadow: 0 4px 8px 0 rgba(0, 0, 0, 0.2), 0 6px 15px 0 rgba(0, 0, 0, 0.19); color: black; background-color: white; font-size:1.0em;" |
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| − | {|
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| − | |<big>"Your support over the last few weeks has provided DND a '''meaningful uplift in our capacity'''. Huge thanks!"</big> <br> ~ Department of National Defence </big>
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| − | |}
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| − | |}
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| − | </div><div style="display:inline-table">
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| − | | style="border-left: 10px solid #627dd0; border-right: 10px solid #627dd0; box-shadow: 0 4px 8px 0 rgba(0, 0, 0, 0.2), 0 6px 15px 0 rgba(0, 0, 0, 0.19); color: black; background-color: white; font-size:1.0em;" |
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| − | {|
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| − | |<big>"We’ve truly benefited from your incredible '''talents, insights, and dedication throughout this engagement'''. Looking forward to when our paths cross again."</big><br> ~ Public Services and Procurement Canada </big><br>
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| − | |}
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| − | |}
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| − | </div>
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| − | ==<div id="For more information, contact us">'''<big><big>For more information, contact us</big></big>'''==
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| − | <big> If you are interested in working with us or want to learn more about what we do, reach out to us at [mailto:surgeteam-equipederenfort@csps-efpc.gc.ca surgeteam-equipederenfort@csps-efpc.gc.ca] or visit our [https://gcxgce.sharepoint.com/teams/1000611/ GCXchange site]. Our Director General (DG) is also available for exploratory and informal discussions: [mailto:paul.pilieci@csps-efpc.gc.ca paul.pilieci@csps-efpc.gc.ca]</big>
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| − | |}
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