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New Undergrad Bulletin.Qxp
The Felician Sisters conduct three colleges: Felician College Lodi and Rutherford, New Jersey 07644 Villa Maria College Buffalo, New York 14225 Madonna University Livonia, Michigan 48150 MADONNA UNIVERSITY The , the first initial of Madonna, is a tribute to Mary, the patroness of Madonna University. The flame symbolizes the Holy Spirit, the source of all knowledge, and signifies the fact that liberal arts education is the aim of Madonna University whose motto is Sapientia Desursum (Wisdom from Above). The upward movement of the slanted implies continuous commitment to meeting the ever growing educational needs and assurance of standards of academic quality. The box enclosing the is symbolic of unity through ecumenism. The heavy bottom line of the box signifies the Judeo-Christian foundation of the University. (The Madonna University logo was adopted in 1980) Madonna University guarantees the right to equal education opportunity without discrimination because of race, religion, sex, age, national origin or disabilities. The crest consists of the Franciscan emblem, which is a cross and the two pierced hands of Christ and St. Francis. The Felician Sisters' emblem is the pierced Heart of Mary, with a host symbolizing the adoration of the Eucharist through the Immaculate Heart, to which the Community is dedicated. The University motto, Sapientia Desursum, is translated “Wisdom from Above”. MADONNA UNIVERSITY Undergraduate Bulletin Volume 38, 2004 - 2006 (Effective as of Term I, 2004) Madonna University 36600 Schoolcraft Livonia, Michigan 48150-1173 (734) 432-5300 (800) 852-4951 TTY (734) 432-5753 FAX (734) 432-5393 email: [email protected] Web site: http://www.madonna.edu Madonna University guarantees the right to equal educational opportunity without discrimination because of race, religion, sex, age, national origin, or disabilities. -
Requirements Capture for Medical Device Design
INTERNATIONAL CONFERENCE ON ENGINEERING DESIGN ICED 03 STOCKHOLM, AUGUST 19-21, 2003 REQUIREMENTS CAPTURE FOR MEDICAL DEVICE DESIGN J Ward, S Shefelbine and P J Clarkson Abstract There are many examples from the medical device design industry where poor requirements capture practice has led to post-market problems, including patient morbidity and mortality. There is a clear need to improve this process. The purpose of this paper is to present the results of several years of study by five researchers into the requirements capture process in this area of industry and to highlight the need by industry for further guidance. Various research methods were used to investigate the requirements capture problem and to develop and evaluate a workbook which provides guidance for designers. The workbook consists of a package of methods: a functional analysis approach, a matrix-based checklist and advice on regulatory requirements. It has been refined over the years and is now published [1]. The matrix also forms part of a publication for the UK Department for Trade and Industry [2], and a web version is under development. Keywords: best practice, introduction of methods, medical devices, requirements capture 1 Introduction Medical device design involves the creation of healthcare products and the manufacturing and testing equipment used to produce them. It is a large and diverse industry, which often manufactures safety-critical products. Worryingly, however, device design-related problems can – and do regularly – cause serious difficulties for device patients and operators, ranging from near-misses to death. Since the mid 1990s, regulatory authorities world-wide have placed design controls on the design of medical devices and manufacturing equipment in order to identify such deficiencies before full production commences. -
Coil Loop for Exhaust-Air Energy Recovery
Coil loop for exhaust-air energy recovery An exhaust-air energy-recovery system can reduce utility costs by capturing and using energy that would normally be lost to the Devices (including total- exhaust air stream. energy wheels and heat pipes) other than the coil A coil loop can be applied either to the primary supply-air system loop described here can or to independent systems such as the dedicated ventilation exchange sensible and/or system that serves a laboratory. The effectiveness of the coil latent heat for energy loop typically ranges from 45 percent to 60 percent for recovery. recovering sensible heat. Figure 4–2 illustrates how the coil loop works. During the heating season (Inset A), heat extracted from the exhaust air stream (EA) warms the air brought into the building. Operation of the coil loop is limited to prevent the supply-air temperature from exceeding the cooling set point. (This condition is most likely to occur on mild days during the spring and fall.) Preconditioning the outdoor air (OA) in this manner reduces the heating load, which in turn reduces the energy consumption of the HVAC system. Figure 4–2 Operating modes for coil-loop energy recovery Inset A • winter operation Inset B • summer operation Coil-loop operation reverses during the cooling season (Inset B). Sensible heat is extracted from the air brought into the building and is rejected to the cooler and drier exhaust air stream. This time, preconditioning by the coil loop reduces the cooling load and, in turn, the energy consumption of the HVAC system. -
Copyrighted Material
INDEX A Bertsch, Fred, 16 Caslon Italic, 86 accents, 224 Best, Mark, 87 Caslon Openface, 68 Adobe Bickham Script Pro, 30, 208 Betz, Jennifer, 292 Cassandre, A. M., 87 Adobe Caslon Pro, 40 Bézier curve, 281 Cassidy, Brian, 268, 279 Adobe InDesign soft ware, 116, 128, 130, 163, Bible, 6–7 casual scripts typeface design, 44 168, 173, 175, 182, 188, 190, 195, 218 Bickham Script Pro, 43 cave drawing, type development, 3–4 Adobe Minion Pro, 195 Bilardello, Robin, 122 Caxton, 110 Adobe Systems, 20, 29 Binner Gothic, 92 centered type alignment Adobe Text Composer, 173 Birch, 95 formatting, 114–15, 116 Adobe Wood Type Ornaments, 229 bitmapped (screen) fonts, 28–29 horizontal alignment, 168–69 AIDS awareness, 79 Black, Kathleen, 233 Century, 189 Akuin, Vincent, 157 black letter typeface design, 45 Chan, Derek, 132 Alexander Isley, Inc., 138 Black Sabbath, 96 Chantry, Art, 84, 121, 140, 148 Alfon, 71 Blake, Marty, 90, 92, 95, 140, 204 character, glyph compared, 49 alignment block type project, 62–63 character parts, typeface design, 38–39 fi ne-tuning, 167–71 Blok Design, 141 character relationships, kerning, spacing formatting, 114–23 Bodoni, 95, 99 considerations, 187–89 alternate characters, refi nement, 208 Bodoni, Giambattista, 14, 15 Charlemagne, 206 American Type Founders (ATF), 16 boldface, hierarchy and emphasis technique, China, type development, 5 Amnesty International, 246 143 Cholla typeface family, 122 A N D, 150, 225 boustrophedon, Greek alphabet, 5 circle P (sound recording copyright And Atelier, 139 bowl symbol), 223 angled brackets, -
Report of the Manager Santa Fe Operations U.S. Atomic
- Foreword The purpose of this report is to summarize in broad outline the mission accom- plishments and the management programs of Santa Fe Operations during the period from July 1, 1950, through December 31, 1953. The report is not intended to record the full management achievement; it is intended to provide a summary which will serve as a back- ground for understanding the complex weapons operation. The body of the report covers three full fiscal years, to July 1, 1953. The first chapter summarizes the full report and additionally records the major actions of the next six months to January 1, 1954. To provide a better perspective, background of the 1947-1950 period is included where essential. It was considered preferable not to include a section on management projections beyond January 1, 1954, although such pro- 1 1 jections are indicated where they benefit understanding. The previous report, covering SFO’s first three years of stewardship, was devoted largely to the programmatic and community operations at Los Alamos. It reflected the proportion of weapons activity, and consequently of management activity, then centered in Los Alamos. It necessarily reflected the key importance during that period of the 3 development of the Los Alamos community. 1 The present report records the major expansion of development, production and test facilities which occurred after July 1, 1950. It covers the full period of the Korean I War and almost the full period of the thermonuclear development program. It covers the full period of continental tests. It records the considerable expansion of the contrac- tor structure and the development of Santa Fe Operations Office as an operations-wide headquarters and field activity. -
A Guide to Quarkcopydesk 8.5 CONTENTS
A Guide to QuarkCopyDesk 8.5 CONTENTS Contents About this guide...............................................................................9 What we're assuming about you............................................................................9 Where to go for help..............................................................................................9 Conventions..........................................................................................................10 Technology note...................................................................................................10 The user interface...........................................................................11 Menus...................................................................................................................11 QuarkCopyDesk menu (Mac OS only)...........................................................................11 File menu.......................................................................................................................12 Edit menu......................................................................................................................12 Style menu.....................................................................................................................13 Component menu.........................................................................................................15 View menu.....................................................................................................................15 -
Beyond Design Controls 101: Following the Regulation Vs
Beyond Design Controls 101: Following the Regulation vs. Understanding its Intent Presented by: Michael Drues, Ph.D. President, Vascular Sciences Carlsbad, California and Adjunct Professor of Regulatory Science, Medicine and Biomedical Engineering George Washington University Graduate Dept. of Regulatory Science Cornell University Graduate Dept. of Biomedical Engineering GreenLight.Guru Webinar (January 9, 2020) http://blog.greenlight.guru/topic/mike-drues For questions or more information, call (508) 887 – 9486 or e-mail [email protected] © Copyright 2019 by Vascular Sciences and Michael Drues, Ph.D. All rights reserved. Beyond Design Controls 101: Following the Regulation vs. Understanding its Intent presented by: Michael Drues, Ph.D. Since 1990, FDA has required medical device manufacturers to follow design controls. Outside the US, the EU MDR (formerly MDD) include similar requirements as well. Yet, although manufacturers have design control processes in place, they are not always effective as failure to follow design control requirements is commonly cited in FDA 483’s and warning letters. Clearly having design controls in place is not enough! In addition, because design controls must apply to a wide range of devices, they do not specify in detail what manufacturers must do to meet these requirements. Instead, they establish a framework that manufacturers should follow when developing medical devices. This provides manufacturers the flexibility to apply design controls that both comply with the regulation and are appropriate for the Companies devices and development processes. At a high level, design controls address the design process, i.e., labeling, user needs, design inputs and outputs, design review, verification and validation, etc. -
Community Design and Construction Georgia Institute of Technology College of Architecture and College of Building Construction Spring 2008
Community Design and Construction Georgia Institute of Technology College of Architecture and College of Building Construction Spring 2008 _________________________________________________________________________ Instructor: Mike Watkins Background: MS Arch Concentration in Classical Design, Georgia Tech, 2008 Duany Plater-Zyberk & Company, Director of Town Planning, 19 years B Arch, University of Cincinnati E-mail: [email protected] Cell phone: 301 675 6223 Class time: Tuesdays from 6 pm until 9 pm. Office hours: Appointments made upon request. Course nos.: ARCH 4803, ARCH 8803, BC 4803, BC 8813 _________________________________________________________________________ Description: The course will provide an overview of the principles of smart growth, livable communities and new urbanism, and how these principles are implemented throughout the process of creating communities—including zoning and entitlements, design, branding and marketing, construction and life after the developer leaves. These communities bring together a synergistic mix of uses, incomes, and age groups and feature a variety of housing types, parking conditions, and building structures organized around coherent systems of public spaces. The course will study examples at a variety of urban scales and densities and teach students how to understand them in relation to the rural-to-urban transect. Local examples and guest lecturers from the Atlanta design and construction professions will also provide opportunities to examine the impact of these communities on social, economic, transportation and other relevant systems. Generally, the course will cover of three broad types of material: I. Principles The Lexicon of the New Urbanism The Charter of the New Urbanism The Transect, Zoning and the transect-based Smart Code II. Precedents and Projects Serenbe Watkins Syllabus 08 02 05.doc Page 1 of 4 Community Design and Construction Georgia Institute of Technology College of Architecture and College of Building Construction Spring 2008 Glenwood Park (or Atlantic Station or Vickery) Kentlands III. -
Design-Build Manual
Design-Build Manual M 3126.07 August 2021 Construction Division Design-Build Program Americans with Disabilities Act (ADA) Information Title VI Notice to Public It is the Washington State Department of Transportation’s (WSDOT) policy to assure that no person shall, on the grounds of race, color, national origin or sex, as provided by Title VI of the Civil Rights Act of 1964, be excluded from participation in, be denied the benefits of, or be otherwise discriminated against under any of its programs and activities. Any person who believes his/her Title VI protection has been violated, may file a complaint with WSDOT’s Office of Equal Opportunity (OEO). For additional information regarding Title VI complaint procedures and/or information regarding our non- discrimination obligations, please contact OEO’s Title VI Coordinator at 360-705-7090. Americans with Disabilities Act (ADA) Information This material can be made available in an alternate format by emailing the Office of Equal Opportunity at [email protected] or by calling toll free, 855-362-4ADA(4232). Persons who are deaf or hard of hearing may make a request by calling the Washington State Relay at 711. Foreword The Design-Build Manual has been prepared for Washington State Department of Transportation Engineering Managers, Design Engineers, Construction Engineers, Evaluators, Project Engineers, and other staff who are responsible for appropriately selecting, developing, and administering projects using design-build project delivery. This manual describes the processes and procedures for procuring and administering design-build contracts. Decisions to deviate from the guidance provided in this manual must be based on representing the best interests of the public and are to be made by the individual with appropriate authority. -
Remedy Volume 3 April ‘21
red pocket. REMEDY VOLUME 3 APRIL ‘21 Letter from Table of the Editor Contents It’s been a difficult time. CONTACT US TRADITIONAL MEDICINE 4 Rena Su Last year was a year of tragedy - tinged by a global pandemic, the death of George Floyd, an anti-Asian hate crisis, and the crushing feeling of being alone. Isolated. Website: A DECEMBER DAY 6 redpocketmagazine.ca Kun Zhu However, Red Pocket Magazine’s team was determined to bring some form of goodness back into these moments. After much deliberation, we decided to encourage others to find “Remedy.” We asked E-mail: BETWEEN THE LINES 8 for stories that showed how we heal from emotions just as we heal from a fever or a headache. [email protected] Sophia Guan I must say, I was truly impressed by the sheer quality of the work we received. Every piece was Facebook: ALL I KNOW 12 beautifully crafted and embodied the message we wanted to convey with “Remedy”. facebook.com/redpocketmagazine Anonymous Submission If you find a soothing herbal broth to be your source of comfort, then Rena Su’s “Traditional Instagram: STANDING OVATION 15 Medicine” and Ian Wu’s “High Fever” might resonate with you. @redpocketmagazine Tiya Tanaka If you’ve ever experienced the long-lasting effects of racial discrimination, you might empathize with TikTok: RESPONSE TO FUSION 16 Jasmin Rostamirad’s “Once Upon a Time”. @redpocketmagazine Diane Huang If you find respite with nature and the outdoors, you might enjoy Beverly Ma’s painting “Fish and DAYLIGHT 17 Leaves” or Kun Zhu’s poem “Daylight”. -
Medical Device Cybersecurity – a Marriage of Safety and Security
Medical Device Cybersecurity – A Marriage of Safety and Security 121st AFDO Annual Education Conference Medical Devices Track June 20th, 2017 By: Armin Torres, Principal Consultant 1 Cyber Security Overview Cybersecurity – is the process of preventing unauthorized access, modification, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Requires Medical Device Manufacturers to consider appropriate Information Security Controls for: • Physical and Logical Access • Data and Record Controls • Secure Communications • Protection for Essential Clinical Performance 2 Medical Device Cybersecurity • Device Cybersecurity is a Life Cycle process which starts with initial design and ends with decommissioning and disposal of devices. • Key QMS areas impacted include Design Controls, Production & Process Controls, and Supply Chain elements. • Robust Security is not something that can be bolted on but must be designed into medical products from inception • Cybersecurity Risks are different than Patient Safety Risks but some Cyber risks may impact patient safety • Threats and Vulnerabilities for Cyber Risk much broader in scope than typical Safety Hazard, Harm, and device failure mode assessment processes. • Impacts to Business environment substantial including potential for: • Degradation or Disruption of Customer Business • Increase costs due to breaches and non-compliance to regulatory requirements • Brand Recognition 3 The New Cyber Attack Landscape -
Design Control Guidance
Center for Devices and Radiological Health DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS This Guidance relates to FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001 March 11, 1997 FOREWORD To ensure that good quality assurance practices are used for the design of medical devices and that they are consistent with quality system requirements worldwide, the Food and Drug Administration revised the Current Good Manufacturing Practice (CGMP) requirements by incorporating them into the Quality System Regulation, 21 CFR Part 820. An important component of the revision is the addition of design controls. Because design controls must apply to a wide variety of devices, the regulation does not prescribe the practices that must be used. Instead, it establishes a framework that manufacturers must use when developing and implementing design controls. The framework provides manufacturers with the flexibility needed to develop design controls that both comply with the regulation and are most appropriate for their own design and development processes. This guidance is intended to assist manufacturers in understanding the intent of the regulation. Design controls are based upon quality assurance and engineering principles. This guidance complements the regulation by describing its intent from a technical perspective using practical terms and examples. Draft guidance was made publicly available in March, 1996. We appreciate the many comments, suggestions for improvement, and encouragement we received from industry, interested parties, and the Global Harmonization Task Force (GHTF) Study Group 3. The comments were systematically reviewed, and revisions made in response to those comments and suggestions are incorporated in this version. As experience is gained with the guidance, FDA will consider the need for additional revisions within the next six to eighteen months.