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Archive for Medical Device Alliance NewsletterFebruary 2010, published on February 22nd, 2010Clinician of the Month: Lesa Hobright -TurnerContinuous Improvement in a Regulated Environment Companies in the News: Anulex, AGA Medical, AMS View Issue January 2010, published on January 25th, 2010Risk Evaluation of Adverse EventsStatistics and FDA Advisory Panels Companies in the News: Medtronic, Cardiovascular Systems, Hansaton View Issue December 2009, published on December 15th, 2009Applying Lean Manufacturing Principles to Regulated CompaniesClinician of the Month: Cristy DeLaCruz Companies in the News: ATS, Apnex, and Smiths Medical View Issue November 2009 Issue, published on November 23rd, 2009Book Review: SOPs in Handbooks and Manuals Versus Web ExamplesStatistics, the FDA and Product Labeling Companies in the News: Arkray, BridgePoint Medical, & Entellus View Issue October 2009 Issue, published on October 16th, 2009Clinician of the Month: Charis SugdenCompanies in the news: SurModics, Cardiovascular Systems, Boston Scientific 6 Sigma Office Solutions View Issue September 2009 Issue, published on September 17th, 2009Book Review: PROs and Registries – What are these?Companies in the News: St Jude, Medrad/Possis, and Thermo Fisher Scientific Financing When The Bank Says No View Issue August 2009 Issue, published on August 27th, 2009Clinician of the Month: Kari LoingProject Definition – A Critical First Step to Process Improvement Company Headlines: NeuroVasx, ATS, Cardiovascular Systems View Issue June 2009 issue, published on May 31st, 2009Clinician of the Month: Wayne CarlsonCompanies in the News: Inspire Medical, Disc Dynamics, EV3 Need a Coach? Select wisely View Issue May 2009 issue, published on April 30th, 2009Subgroup Analyses: Good Science, Data Mining and the FDAThe Nimble Workforce Companies in the News: St. Jude Medical and Torax Medical View Issue April 2009 issue, published on March 31st, 2009Clinician of the Month: Jane Johnson with Transoma MedicalLocal Headlines: Atritech, NeuroVasX, St. Jude Medical, GE Healthcare View Issue March 2009 issue, published on February 28th, 2009(Statistical) Power To The PeopleBook Review: Both Texts are Solid Additions to Your Library Companies in the News - Transoma, Inspire Medical and Apnex Medical View Issue February 2009 issue, published on January 31st, 2009Activity-Based Fees: Manage costs when outsourcing your clinical trialsClinician of the Month: Carl Beaurline Companies in the News: St. Jude Medical, Arkay USA, Transoma Medical View Issue January 2009 issue, published on December 31st, 2008Bayesian Statistics: Fact And FictionThe Many Aspects of Clinical Trials - Literature Review and Summary Strategies for Publication Planning View Issue December 2008 issue, published on November 30th, 2008Medical Device Product Recall PreventionClincian of the Month: Jennifer Maloney Companies in the News: St. Jude, ev3, and AGA Medical View Issue November 2008 issue, published on October 31st, 2008Am I Informed?Issues in the Design and Analysis of Pre-clinical Studies Local Industry News - SurModics, Cardiovascular Systems, and Lumen View Issue October 2008 issue, published on September 30th, 2008Local News - Advanced Circulatory Systems, St. Jude Medical, Acist MedicalPatient Recruiting - Who needs the education? Medical Device Manufacturing and the Regulations View Issue September 2008 issue, published on August 31st, 2008Fraud: What is it? How to detect it? What to do about it?Single Arm Studies: Objective Performance Criteria or Performance Goals Selecting Clinical Study Sites View Issue August 2008 issue, published on July 31st, 2008Medical Device Manufacturing Regulations - Product Recall from the FieldLocal Industry Snapshot: Atritech, St Jude Medical CVRx Clinical Research Staff: Can We Win The Olympic Gold? View Issue July 2008 issue, published on June 30th, 2008The Many Aspects of Clinical Trials: Effective Site MonitoringNoninferiority Clinical Trials Local Industry Snapshot: AGA Medical, SuperDimension, Medtronic View Issue June 2008 issue, published on May 31st, 2008The Search for the Perfect EmployeeMedical Device Manufacturing Regulations, Product Recall from the Field Local Industry Snapshot: Vision Ease, Virtual Radiologic, St. Jude Medical View Issue May 2008 issue, published on April 30th, 2008The Informed Consent Process - Protection of Human SubjectsPractical Adaptive Clinical Study Designs for Medical Devices Local Snapshot: Nonin Medical, American Medical, Medtronic, and Myocor Nonin Medical Inc. announces the release of the first and only wireless fingertip pulse oximeter to system integrators worldwide. The Onyx(R) II, Model 9560 fingertip puls The Search for the Perfect Employee Medical Device Manufacturing Regulations, Product Recall from the Field Local Industry Snapshot: Vision Ease, Virtual Radiologic, St. Jude Medical The Many Aspects of Clinical Trials: Effective Site Monitoring Noninferiority Clinical Trials Local Industry Snapshot: AGA Medical, SuperDimension, Medtronic Medical Device Manufacturing Regulations - Product Recall from the Field Local Industry Snapshot: Atritech, St Jude Medical CVRx Clinical Research Staff: Can We Win The Olympic Gold? Fraud: What is it? How to detect it? What to do about it? Single Arm Studies: Objective Performance Criteria or Performance Goals Selecting Clinical Study Sites Bayesian Statistics: Fact And Fiction The Many Aspects of Clinical Trials - Literature Review and Summary Strategies for Publication Planning Activity-Based Fees: Manage costs when outsourcing your clinical trials Clinician of the Month: Carl Beaurline Companies in the News: St. Jude Medical, Arkay USA, Transoma Medical (Statistical) Power To The People Book Review: Both Texts are Solid Additions to Your Library Companies in the News - Transoma, Inspire Medical and Apnex Medical Clinician of the Month: Jane Johnson with Transoma Medical Local Headlines: Atritech, NeuroVasX, St. Jude Medical, GE Healthcare Subgroup Analyses: Good Science, Data Mining and the FDA The Nimble Workforce Companies in the News: St. Jude Medical and Torax Medical Clinician of the Month: Wayne Carlson Companies in the News: Inspire Medical, Disc Dynamics, EV3 Need a Coach? Select wisely View Issue April 2008 issue, published on March 31st, 2008Medical Device Manufacturing and the Regulations, Documentation ControlIndustry News: Uroplasty Inc., Medtronic Inc. Starkey Laboratories Challenges in Clinical Trial Enrollment View Issue March 2008 issue, published on February 29th, 2008Aspects of Clinical Trials - Technical Support at Medical Device ImplantThe Clinical Trials Arms Race Local Industry Snapshot View Issue February 2008 issue, published on January 31st, 2008Medical Device Manufacturing and the regulations, trainingEmerging Employee Retention Practices in Manufacturing Companies Local Industry Snapshot View Issue January 2008 issue, published on December 31st, 2007The Many Aspects of Clinical Trials - Investigator and Site TrainingMulticenter Clinical Trials Local Industry Snapshot View Issue December 2007 issue, published on November 30th, 2007Business Mentoring - A Protégé's PerspectiveMedical Device Manufacturing Regulations - Internal Audit Process FDA's Draft Guidance Overview View Issue November 2007 issue, published on October 31st, 2007The Many Aspects of Clinical Trials - The Clinical TeamThe Art of Sample Size Calculations How do you Measure Up? View Issue October 2007 issue, published on September 30th, 2007Milestones and Setting Expectations for Clinical ProjectsSelecting Good Study Sites Medical Device Manufacturing and the Regulations: View Issue September 2007 issue, published on August 31st, 2007Meeting Your Enrollment GoalsBusiness and Operations' Strategy Sync The Most Significantly Misunderstood Topic in Research View Issue August 2007 issue, published on July 31st, 2007The Role of the Clinical Department in Product Development CycleThe Importance of the Informed Consent Process Medical Device Manufacturing and the Regulations View Issue July 2007 issue, published on June 30th, 2007Continuous Improvement in a Regulated EnvironmentThe Power of Randomized Experiments Reauthorizing Medical Device User Fees through the year 2012 View Issue June 2007 issue, published on May 31st, 2007The Clinical Research Associate's DegreeMedical Device Manufacturing and the Regulations Reimbursement and Its Role in Regulatory Strategies View Issue May 2007 issue, published on April 30th, 2007Blinding in Medical Device TrialsIntegrating Lean and Six-Sigma Agreeing on Clinical Study Objectives Isn't Easy View Issue April 2007 issue, published on March 31st, 2007What Makes a Good Clinical Research Associate?Medical Device Manufacturing and Regulations: The Audit Foreign Clinical Trials, Lessons Learned View Issue March 2007 issue, published on February 28th, 2007Adverse Event Reporting: Considerations and Regulatory RequirementsStatistical Lessons from the Acorn Cardiovascular Experience View Issue February 2007 issue, published on January 31st, 2007Clinical Post-Market Studies: Mere Days Away from Public ScrutinyEuropean Class IIa Medical Device Approval Routes Medical Device Manufacturing and Regulations: Part III View Issue January 2007 issue, published on December 31st, 2006Clinical Trials: Why Go Global?Third Party Reviewers: A First Rate Process? Medical Device Manufacturing and Regulations: Overview of FDA's Postmarket Program for Medical Devices The Problem of Missing Data in Clinical Trials PERVASIVE PARANOIA: What does the Acorn dispute resolution mean? Participate in the 2007 Manufacturing Compensation Benefits Survey View Issue November 2006 issue, published on October 31st, 2006Medical Device CRO or Independent Consultant: How Do You Choose?Can A Statistician Build A Better Mouse Trap - Or a Better Clinical Trial Risk Management, Regulation, and Relevant Steps: Thoughts on Optimizing Process View Issue October 2006 issue, published on September 30th, 2006Tight Submission Strategy: Pursuing Only Needed DataHUD/HDE: Is There a Quick Way to Market? Medical Device Manufacturing and Regulations: Part 1 of a Series View Issue |
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