This document contains the personal and contact information, educational background, qualifications, skills, and work experience of David Eastman. It details his roles as an SHEQ Manager, Production Supervisor, Stores and Despatch worker, and various other safety, logistics and operations positions over his career. He has qualifications in health and safety, quality management, and hazardous materials handling.
This document lists the names of 22 famous actors, musicians, and businesspeople including Clint Eastwood, Elvis Presley, Arnold Schwarzenegger, Michael Jackson, Morgan Freeman, Bruce Willis, Alan Rickman, Sir Sean Connery, Steve Jobs, Sir Patrick Stewart, Tom Cruise, William Shatner, Tobey Maguire, Sir Ben Kingsley, Robert De Niro, Bill Murray, Russell Crowe, Mickey Rourke, Joaquin Phoenix, Charlie Sheen, Simon Pegg, and Simon Cowell. The document concludes with the letters "PPS Mana".
The document discusses the Vegetable Kingdom, which includes plants divided into two groups: plants without flowers, such as ferns and mosses that reproduce via spores; and plants with flowers, including gymnosperms like pine trees and angiosperms like apple trees. It also covers photosynthesis and how plants live in different parts of the world depending on their ability to survive local conditions.
09/08/2015 - Rolling Hills Community Church, Lago Vista Texas. Men't Bible Study. Introduction Part 1 to The Story. Overview of the Bible and How to Study. Presented by Chris Reighley
Presentation delivered at the RMD 2016 conference (European Symposium on the New Agreed Draft Regulations on Medical Devices) in Prague on 7 November 2016
This document contains the personal and contact information, educational background, qualifications, skills, and work experience of David Eastman. It details his roles as an SHEQ Manager, Production Supervisor, Stores and Despatch worker, and various other safety, logistics and operations positions over his career. He has qualifications in health and safety, quality management, and hazardous materials handling.
This document lists the names of 22 famous actors, musicians, and businesspeople including Clint Eastwood, Elvis Presley, Arnold Schwarzenegger, Michael Jackson, Morgan Freeman, Bruce Willis, Alan Rickman, Sir Sean Connery, Steve Jobs, Sir Patrick Stewart, Tom Cruise, William Shatner, Tobey Maguire, Sir Ben Kingsley, Robert De Niro, Bill Murray, Russell Crowe, Mickey Rourke, Joaquin Phoenix, Charlie Sheen, Simon Pegg, and Simon Cowell. The document concludes with the letters "PPS Mana".
The document discusses the Vegetable Kingdom, which includes plants divided into two groups: plants without flowers, such as ferns and mosses that reproduce via spores; and plants with flowers, including gymnosperms like pine trees and angiosperms like apple trees. It also covers photosynthesis and how plants live in different parts of the world depending on their ability to survive local conditions.
09/08/2015 - Rolling Hills Community Church, Lago Vista Texas. Men't Bible Study. Introduction Part 1 to The Story. Overview of the Bible and How to Study. Presented by Chris Reighley
Presentation delivered at the RMD 2016 conference (European Symposium on the New Agreed Draft Regulations on Medical Devices) in Prague on 7 November 2016
The document discusses key changes and requirements regarding the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and the European database on medical devices (Eudamed). Some of the main points discussed include:
- Eudamed will contain integrated electronic systems for European UDI, registration of devices and economic operators, scrutiny applications, certificates, clinical investigations, vigilance, and market surveillance.
- Traceability requirements will require manufacturers, distributors, and importers to cooperate to achieve appropriate traceability levels and identify economic operators in the supply chain.
- Unique Device Identification (UDI) must be assigned and placed on labels and packaging. Registrations of devices and economic
Laryngeal Mask Airway & Igel - An IntroductionHIRANGER
The document provides information about the Laryngeal Mask Airway (LMA) and I-gel devices for airway management:
[1] It discusses the indications, contraindications, equipment, and step-by-step process for inserting the LMA. Proper sizing, lubrication, and positioning are emphasized.
[2] Placement must be verified by ensuring equal breath sounds on both sides and absence of sounds over the epigastrium. Problems like improper deflation or folding can occur.
[3] The I-gel is introduced as a single-use, cuffless airway device with an integral gastric channel and epiglottis blocking ridge to facilitate insertion.
This document contains information from Devaprakasam D, a Professor of Mechanical Engineering, on the topics of research ethics and methodology. It defines ethics, research ethics, provides examples of ethical norms in research, summarizes codes and policies for research ethics, and includes two case studies on ethical issues in research. The document is intended to educate researchers on proper ethical conduct and preventing misconduct.
The document discusses medical device adverse event reporting requirements, including definitions of reportable events and timelines for submitting reports to regulatory agencies. It provides an overview of the classification system for medical devices and regulations around reporting malfunctions, deaths and serious injuries caused by devices. Reporting requirements and challenges involving software as a medical device are also reviewed.
Wykonawcy przyszłości - platformy motywacyjneGrzegorz Osóbka
Zarządzanie złożonymi rynkami technicznymi wymaga logicznego wiązania i podnoszenia siatki powiązań i zależności między wykonawcami, dystrybutorami, inwestorami, projektantami i inwestorami.
Design for Manufacturability Rapid Fire April Bright
Design for manufacturability (DFM) is a broadly-implemented step in today’s development process to ensure that a designed product can actually be manufactured. While the concept sounds simple, there are nuances to every supplier relationship and every new process.
Three suppliers—a contract manufacturer, additive manufacturer and plastics company—will each spend 15 minutes answering the following question: With orthopaedic customers, our greatest DFM pain point is ___ and the best strategy to change that is ___.
OEMs will learn best practices and ways to approach DFM with their supplier partners.
Steps to Compliance with the European Medical Device RegulationsApril Bright
The document summarizes proposed changes to the European Medical Device Regulations (MDR). It discusses expanding the regulations to cover clinical investigations in Europe and adverse incident reporting. It outlines the classification system for medical devices and conformity assessment procedures. Key aspects include new definitions, unique device identification requirements, essential safety and performance standards, and requirements for economic operators, notified bodies, and identification/traceability of devices. The European database EUDAMED is also mentioned.
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.
The document discusses key changes and requirements regarding the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and the European database on medical devices (Eudamed). Some of the main points discussed include:
- Eudamed will contain integrated electronic systems for European UDI, registration of devices and economic operators, scrutiny applications, certificates, clinical investigations, vigilance, and market surveillance.
- Traceability requirements will require manufacturers, distributors, and importers to cooperate to achieve appropriate traceability levels and identify economic operators in the supply chain.
- Unique Device Identification (UDI) must be assigned and placed on labels and packaging. Registrations of devices and economic
Laryngeal Mask Airway & Igel - An IntroductionHIRANGER
The document provides information about the Laryngeal Mask Airway (LMA) and I-gel devices for airway management:
[1] It discusses the indications, contraindications, equipment, and step-by-step process for inserting the LMA. Proper sizing, lubrication, and positioning are emphasized.
[2] Placement must be verified by ensuring equal breath sounds on both sides and absence of sounds over the epigastrium. Problems like improper deflation or folding can occur.
[3] The I-gel is introduced as a single-use, cuffless airway device with an integral gastric channel and epiglottis blocking ridge to facilitate insertion.
This document contains information from Devaprakasam D, a Professor of Mechanical Engineering, on the topics of research ethics and methodology. It defines ethics, research ethics, provides examples of ethical norms in research, summarizes codes and policies for research ethics, and includes two case studies on ethical issues in research. The document is intended to educate researchers on proper ethical conduct and preventing misconduct.
The document discusses medical device adverse event reporting requirements, including definitions of reportable events and timelines for submitting reports to regulatory agencies. It provides an overview of the classification system for medical devices and regulations around reporting malfunctions, deaths and serious injuries caused by devices. Reporting requirements and challenges involving software as a medical device are also reviewed.
Wykonawcy przyszłości - platformy motywacyjneGrzegorz Osóbka
Zarządzanie złożonymi rynkami technicznymi wymaga logicznego wiązania i podnoszenia siatki powiązań i zależności między wykonawcami, dystrybutorami, inwestorami, projektantami i inwestorami.
Design for Manufacturability Rapid Fire April Bright
Design for manufacturability (DFM) is a broadly-implemented step in today’s development process to ensure that a designed product can actually be manufactured. While the concept sounds simple, there are nuances to every supplier relationship and every new process.
Three suppliers—a contract manufacturer, additive manufacturer and plastics company—will each spend 15 minutes answering the following question: With orthopaedic customers, our greatest DFM pain point is ___ and the best strategy to change that is ___.
OEMs will learn best practices and ways to approach DFM with their supplier partners.
Steps to Compliance with the European Medical Device RegulationsApril Bright
The document summarizes proposed changes to the European Medical Device Regulations (MDR). It discusses expanding the regulations to cover clinical investigations in Europe and adverse incident reporting. It outlines the classification system for medical devices and conformity assessment procedures. Key aspects include new definitions, unique device identification requirements, essential safety and performance standards, and requirements for economic operators, notified bodies, and identification/traceability of devices. The European database EUDAMED is also mentioned.
CAPA: Using Risk-Based Decision-Making Toward ClosureApril Bright
Implementing a risk‐based CAPA process within a QMS is a necessity in the improvement of controls aligned with product and process non-conformances, adverse events, audit findings, complaints, etc. Making decisions concerning scope and extent about these “defectives” is a modern and cost-saving approach to improvement and compliance. Every non-conformity does not force you to open a corrective action. While almost every problematic issue needs at least a correction, the biggest payback is to use corrective actions on systemically-driven problems that are repetitive and recurring.
Applying the methods of determining risk to the device’s complete life cycle will give your company a complete look at all of the device’s risks—including those relative to processes. Manufacturers should be able to justify that they have reduced the risks as far as possible as part of their risk management plan and ongoing corrective and preventive actions.