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Courses

  • 401 Request Info

    Software Risk Analysis Tools for Medical Devices and Risk Mitigation

    The FDA recalls related to software performance are on the increase for at least five years at the time of this writing. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA. Similar to hardware, software also has hazards (any source of harm) and hazardous situations which transform a hazard into harm. We must identify hazards and identify what event can turn them into harm and write software specifications to prevent such combinations. The risk management tools such as FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis) can help to mitigate software risks. These tools are covered in the Chapter 4. The mitigations from using the tools become the new requirements in the software specification
  • 402 Request Info

    Medical Device Software Development

    This seminar is mainly based on the IEC62304:2006 standard and will introduce the main elements and requirements for the development of modern software systems for medical devices. Emphasis is placed on understanding the underlying principles that generate the requirements of the standard, to understand strengths, the shortcomings and weak parts of the standard and give practical, proven guidance on how to implement the requirements necessary for regulatory approval. This seminar goes beyond teaching the mere content of the standard, but will provide the toolset to understand the underlying engineering principles that allow a justifiable interpretation of potential ambiguities of regulatory requirements. Understanding the basic principles of risk management, the failure modes of software, the architectural approaches available to mitigate software failures and the understanding of test methodologies are vital components to understand the 'spirit' of the requirements.
  • 403 Request Info

    Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices

    Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections.
  • 404 Request Info

    Statistical Techniques for Medical Device Manufacturers

    The FDA's Quality System Regulation (QSR) requires device manufacturers to identify valid statistical techniques to "establish, control, and verify the acceptability of process capability and product characteristics." When device manufacturers analyze CA&PA; information, they must also use "appropriate statistical methodology". Some manufacturers are not clear about all of this. Others are nervous that their approach is sufficient. In addition, sampling plans must be valid, documented, adequate, and reviewed based on changes. These issues can create a patchwork of techniques without a coherent methodology. This seminar helps resolve the problem.
  • 405 Request Info

    Problem Solving and Root Cause Analysis - the Key to an Effective CAPA System

    This program is designed to provide participants with: • Understanding and developing an effective Corrective and Preventive Action System • An understanding of a structured problem solving process • Tools and techniques to perform root causes analyses • The use of facts and data to eliminate the use and identification of ineffective solutions.
  • 406 Request Info

    Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced

    Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools
  • 407 Request Info

    Applied Statistics for QA, QC, Manufacturing, and Design Control

    The 2-day seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics. Basic vocabulary and concepts are then reviewed and discussed. The flow of subsequent topics over the 2 days is as follows: • How to calculate confidence intervals (for proportions and for measurements), including a discussion of how to choose sample size • How to perform an interpret t-Tests, including consideration of "significance", "p-values", "power" and sample-size considerations • How to perform calculation of confidence/reliability for attribute data
  • 408 Request Info

    Design Control for Professionals

    This training program will focus on the consequences of poor design control, Failure Modes Effects Analysis (FMEA), design control segments, and more. Design control has been a legal requirement for over 30 years, yet many firms fail to take full advantage of a controlled method for introducing new products or changing existing products costing millions of dollars and injuring both patients and health care professionals. Who Will Benefit: R&D Personnel Design Engineers Validation Engineers Regulatory Professionals Instructor Profile: An independent QMS consultant, John Chapman, BS, MBA, RAC has over 35 years medical device QMS (Quality Management Systems) experience and over 20 years’ experience with the European Union’s medical device directive, 93/42/EEC. Note: Use coupon code 232082 and get 10% off on registration.
  • 409 Request Info

    Using an IQ / OQ / PQ Approach to Validating Medical Device Software

    This medical device software validation training will show how you can validate software using IQ / OQ / PQ methodologies, typically employed for medical device process validation. Who Will Benefit: This webinar will provide valuable assistance to medical device companies in performing verification and validation testing throughout the product lifecycle. The employees who will benefit include: Systems Engineers Software testers Test Engineers Quality System Auditors Instructor Profile: Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over twenty-five years of experience in the Medical Device industry. Note: Use coupon code 232082 and get 10% off on registration.
  • 410 Request Info

    Equipment Calibration, Maintenance, and Validation: What Auditors Look for in a Controlled Process

    This webinar will discuss the different aspects which auditors generally look in equipment calibration, maintenance and validation and highlight the best practices. Who Will Benefit: This webinar will provide valuable assistance to all personnel involved in process development or equipment calibration/maintenance: R&D management Engineering management Production management Production engineers R&D engineers Instructor Profile: Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Note: Use coupon code 232082 and get 10% off on registration. For Registration: http://www.complianceonline.com/equipment-calibration-maintenance-and-validation-for-auditors-webinar-training-701786-prdw?channel=trainingregistry
  • 411 Request Info

    Understanding the New Custom Device Exemption Guidance

    This training program will review the primary points of the new guidance and review §20(b) of the FD&C Act. It will offer a background of the Act and discuss current updates and changes to the same as well. Who Will Benefit: This webinar will provide valuable assistance to: Regulatory or quality assurance management personnel Project managers Staff involved with custom devices Instructor Profile: Cheryl Wagoner has 20 years of experience in quality assurance, and regulatory affairs. She is currently the principal consultant/owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in quality, regulatory, clinical and compliance in the medical device and pharmaceutical industries. Note: Use coupon code 232082 and get 10% off on registration.
  • 412 Request Info

    Metrics and Dashboards for Quality and Compliance

    This training program will discuss the challenges faced by medical device companies amid close scrutiny by industry regulators. It will also offer best practices for combating lack of transparency in quality/compliance data. Who Will Benefit: Managers of quality and compliance Quality and compliance professionals in medical device companies Individuals preparing information for management review Instructor Profile: Susanne Manz, MBA, MBB, RAC, CQA, is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 413 Request Info

    How to Develop a Medical Device Design Control Program that Will Meet FDA Requirements

    This training program will offer attendees an understanding of the reasons for design control and highlight the key elements of a design control program. Why Should You Attend: This course will explain how to setup and manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. A design control program will also help ensure your projects are completed on time and within budget. Who Will Benefit: Personnel developing or managing medical devices Production management QA/QC Instructor Profile: Edwin Waldbusser is a consultant retired from the industry after 20 years in management of development of medical devices (5 patents). He has been consulting on regulatory issues related to design control, risk analysis and software validation for the last 7 years. Note: Use coupon code 232082 and get 10% off on registration.
  • 414 Request Info

    Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar

    The course is designed for Medical Products Manufacturers. The course will be taught for Medical Devices and Combination Products, but will also be of benefit to Pharmaceutical Manufacturers. Who will benefit: The course is designed for manufacturing professional employees that must interface with or implement product risk management activities in a medical product manufacturing operation. Product Risk Managers Quality Assurance Regulatory Affairs Research & Development Project Managers Operations Managers Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 415 Request Info

    Do You Really Need To Do A Recall? If So, What Is Required?

    This training program will provide practical pointers on documenting the recall decision. Recall can be a very costly process for a manufacturer. It is really important from a regulatory perspective to properly document the decision process whether a recall is necessary or not. Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Regulatory roles Quality assurance management Manufacturing management responsible for executing recall activities Instructor Profile: Cheryl Wagoner has 20 years of experience in quality assurance, and regulatory affairs. She is currently the principal consultant/owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Note: Use coupon code 232082 and get 10% off on registration.
  • 416 Request Info

    UDI Implementation

    This webinar on UDI implementation will discuss the new requirements set by FDA for Unique Device Identification. Attendees will learn to overcome hurdles in implementing the new process and learn best practices too. Who Will Benefit: This webinar will benefit the professionals working in medical device industries. Regulatory managers Design engineers Labeling specialists Project managers Quality managers Instructor Profile: Daniel O' Leary is president of Ombu Enterprises, LLC, a company offering training and execution in operational excellence, focused on analytic skills and a systems approach to operations management. Note: Use coupon code 232082 and get 10% off on registration.
  • 417 Request Info

    Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Euro

    In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada. Who will benefit: This interactive course is specifically developed for individuals, who are responsible for the design, development, manufacturing, marketing, and distribution of IVD products. This course is highly recommended for personnel involved in any of the following functions: Department Managers (middle management) Research & Development (R&D) Product Design & Development Validation Engineering Regulatory Affairs Note: Use coupon code 232082 and get 10% off on registration.
  • 418 Request Info

    Troubleshooting Ethylene Oxide (EO) Processes

    This EO sterilization training Webinar will discuss the important parameters to measure for the sterility assurance level and actions to take if they are not compliant to the process specification. Why Should You Attend: Ethylene oxide (EO) sterilization is the most complicated of the industrial sterilization methods. It is not uncommon for anomalies to occur during qualification or routine processing. Who Will Benefit: This webinar will provide valuable information to all companies that produce sterile products. QA personnel Validation specialists Manufacturing personnel involved in validations Instructor Profile: Gerry O’Dell, is owner and President of Gerry O'Dell Consulting, a consulting firm based in the United States with medical device and pharmaceutical clients around the world. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 419 Request Info

    How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry

    Though the guidance regarding software in medical devices is not new, there remains some confusion in the industry. This training program will offer some clarity on the subject, and upon completing this session, attendees will understand the elements required for a 510(k) application when the device contains software. Why Should You Attend: The webinar will discuss the structure and level of detail required when a medical device is software or contains software. It will especially focus on the impact of the Level of Concern determination on the required documentation. Who Will Benefit: Regulatory managers Project managers Regulatory specialists who compose 510(k) applications for software Instructor Profile: Cheryl Wagoner has 20 years of experience in quality assurance, and regulatory affairs. Note: Use coupon code 232082 and get 10% off on registration.
  • 420 Request Info

    Equipment Calibration, Maintenance, and Validation: What Auditors Look for in a Controlled Process

    This webinar will discuss the different aspects which auditors generally look in equipment calibration, maintenance and validation and highlight the best practices. Why You Should Attend: FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Who Will Benefit: This webinar will provide valuable assistance to all personnel involved in process development or equipment calibration/maintenance: R&D management Engineering management Production management Instructor Profile: Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Note: Use coupon code 232082 and get 10% off on registration.