Medical Device Safety

Oct 11, 2012

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The importance of reporting adverse incidents. What is an adverse incident? A device-related adverse incident is an event which can produce, or have the potential to produce, unwanted effects involving the safety of patients, users or other people. An adverse incident can arise from shortcomings

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Medical Device Safety

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Medical Device Development

Medical Device Development . Robert Hitchcock, Ph.D. Director of Engineering & Technology Development Sorenson Medical, Inc. What is a Medical Device?.

1.58k views • 25 slides

Medical Device Safety Lifecycle: Improving Patient Safety

272 views • 12 slides

Medical Device Localisation

www.adapt-localization.com. 1 . Medical Localisation The Regulatory Environment. www.adapt-localization.com. "Medical Localisation" ? What's Different?. Safety requirementsRegulatory requirementsFormalised environmentSpecific workflows. www.adapt-localization.com. EU ? Regulatory Requirem

312 views • 17 slides

Medical Device Vigilance

Definitions and legal basis 1.1. Organigramme 1.2. Legal basis 1.3. Definitions 1.3.1. Materiovigilance 1.3.2. Medical Device 1.3.3. Corrective Action 1.3.4. Field Safety Corrective Action (FSCA) 1.3.5. Field Safety Notice (FSN) 2. What shall be notify?

2.11k views • 30 slides

Medical device donations

Medical device donations. Presented By [Presenter Name] [Presenter Title] . Date. Introduction. This document covers: Ensuring that the recipients are actively engaged in all stages of the donation process Ensuring that the needs of the end-users and patients are met

349 views • 20 slides

Medical Device Engineering

Medical Device Engineering. Jim Niederjohn April 2, 2014. Purpose. Discuss the role that engineers play in the medical device industry. Agenda. Jim’s Background Education Career History Medical Devices & Projects Medical Device Engineering Engineering Roles & Responsibilities

1.58k views • 28 slides

Medical Device Standards

Medical Device Standards. HL7 Version 2. Medical Device Standards. Medical Device Standards. Medical Device Standards.

558 views • 4 slides

Medical Device Sector

Medical Device Sector. Medical Device National Registry. Agenda. Introduction Medical Devices National Registry ( MDNR ) Purpose of MDNR Who Should Enroll. Introduction. The MDNR is the first step towards implementing a comprehensive regulating system.

422 views • 20 slides

Implementing Medical Device Regulation and Maintaining Patient Safety

Implementing Medical Device Regulation and Maintaining Patient Safety. Name Nicola Lennard Date October 2011. EU Regulatory System. investigation action. accredit audit. compliance ERs safety, performance. Notified Body quality systems design dossier

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Ensuring Patient Safety in Wireless Medical Device Networks

Ensuring Patient Safety in Wireless Medical Device Networks. Presented by: Eric Flickner Chris Hoffman. Speed vs. Safety.

346 views • 22 slides

Medical Device Training

Medical Device Training. MEDICAL EQUIPMENT TRAINING. MEDICAL DEVICE TRAINERS David Jones David Howard Michelle Hickman-Smith DEPT MEDICAL PHYSICS & CLINICAL ENGINEERING. Management of Equipment Training. Policy OP 34 Available on the Intranet

752 views • 16 slides

Unique Device Identification (UDI) – Enabling the Transformation of Medical Device Safety

Unique Device Identification (UDI) – Enabling the Transformation of Medical Device Safety. Terrie Reed, MSIE Associate Director, Informatics terrie.reed@fda.hhs.gov. History of FDA’s UDI Project. 1999 IOM Report – To Err is Human 2004 FDA Pharmaceutical Barcode Rule

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MEDICAL DEVICE STERILIZATION

MEDICAL DEVICE STERILIZATION. Pacific BioLabs Inc. (510) 964-9000 info@PacificBioLabs.com. OUTLINE – MORNING SESSION. 8:30 Introduction 8:45 General Principles of Sterilization & Validation 9:15 Contract Sterilizers and Testing Laboratories 10:15 Break

683 views • 28 slides

Medical Device Development

Medical Device Development. Robert Hitchcock, Ph.D. Director of Engineering & Technology Development Sorenson Medical, Inc. What is a Medical Device?.

629 views • 25 slides

Medical Device Simulator

Medical Device Simulator. Imagine the possibilities with this powerful Tool. Our team of experts analyze your human interface of your Medical Device and create a PC model. Medical Device Simulator. Your simulation can be utilized for: A design tool for Engineering A giveaway for Marketing

292 views • 9 slides

Medical Device Resources

Medical Device Resources. Fall 2012. Resources. ASM Medical Device Materials database ANSI Medical Device Standards Portal TechStreet for additional ISO Medical Device standards. ASM Medical Device Materials. How to access SearchWorks http://searchworks.stanford.edu/view/7648869

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Medical Device Distributor | Medical Device Marketing

It can be difficult to come up with a marketing strategy that can help boost your medical device line sales. There are often many decision makers and variables involved, your medicinal device,medical marketing marketing treatment, strategy, and sending. We need to take in about your methodology and will ask you. Visit us : http://zizion.com/

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Medical Device Manufacturers

We at Deccan Engineering Works are helping lead the medical device manufacturers business into globalization toward emerging economies. We focus on what the increasing medical market requires No matter which sterilization process is involved or what barrier your product is requesting we can develop an appropriate packaging for it.

32 views • 2 slides

Medical Device Regulation: Implications for Medical Device Manufacturers.

Pepgra offers regulatory consulting for Medical device and IVD companies. We help you in Market entry strategy, risk management, device classification and clinical evaluation reports. Let our team of regulatory experts work to ensure your compliance with all national regulations. Learn More: https://www.pepgra.com/device-manufacturers/

220 views • 13 slides

Medical Device Vigilance

612 views • 30 slides

Ensuring Patient Safety in Wireless Medical Device Networks

Ensuring Patient Safety in Wireless Medical Device Networks. Presented by: Eric Flickner Chris Hoffman. Speed vs. Safety.

240 views • 22 slides

National Medical Device Safety Network Better Together

National Medical Device Safety Network Better Together. 19 th November 2014. Dagmar Luettel Patient Safety Lead NHS England. NAMDET 2014 Annual Conference Manchester Conference Centre. ‘Completing the Picture’. The National Reporting and Learning System (NRLS). www. NHS net.

206 views • 20 slides

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