Medical Devices

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  • 41 Request Info

    European Medical Device Regulation / key changes overview

    Europe's new Medical Devices Regulation 2017/745 (MDR) takes effect in May-2020. That seems like plenty of time, but smart companies should start planning their CE transition strategy right away. With manufacturers all over the world transitioning to the MDR and ISO 13485:2016 in the next few years, Notified Body staff shortages and work backlogs are likely to cause delays. This two-day seminar will provide you insights that allow you to identify the best transition strategy for your company based on your product range, certification cycle, markets you serve, and your Notified Body.
  • 42 Request Info

    Design of Experiments (DOE) for Process Development and Validation

    This course will begin by presenting a primer on statistical analysis, focusing on the methods required for analysis of designed experiments. It will then present the steps to DOE, while demonstrating valuable risk management tools (Ishikawa and FMEA) which can be use pre and post DOE studies. Next, participants will learn to generate and analyze multiple screening and response surface designs; the participants will leave with an understanding of why and how each are used. Then, the participants will learn how results of the studies can be presented. Lastly, using the results of the studies, the risk management tools will then be updated.
  • 43 Request Info

    Spreadsheets for 21 CFR 11 Compliance 2018

    This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).
  • 44 Request Info

    Project Management for Non-Project Managers 2018

    This Project management training will provide you with a solid foundation for managing that first project or to simply sharpen existing project management skills, It is not just important to learn about project management - project management has its own body of knowledge, Also The webinar is designed to build a working understanding of the subject and for a quick start-up for those unanticipated project management assignments.
  • 45 Request Info

    Webinar on Is Your Medical Practice HIPAA Compliant: Requirements for Privacy, Security and Breach Notification

    Attend this webinar to learn how to reduce the risk of penalties in your practice and tips for avoiding breaches and learn about real-life HIPAA compliance issues. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 46 Request Info

    Validating Radiation Sterilization for Medical Products

    Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
  • 47 Request Info

    Purchasing Control Essentials for Medical Devices

    This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls!This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control. You'll learn about the essential elements of purchasing control and how you can translate them into your procedures. We'll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities.
  • 48 Request Info

    Effective Design of Experiments Strategies

    This webinar focuses on DOE strategies, and explains use of DOEs during process validation, The effective and progressive use of a Screening DOE, a Mapping DOE and a Robust Process DOE will lead to a better understanding of the process and the location of the best optimum.
  • 49 Request Info

    Design Controls for Medical Devices

    This 3-hour webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. An effective and efficient design control process results in a predictable product development process with improved quality and compliance result. This webinar can help you create a design control process that is a competitive strength for your company.
  • 50 Request Info

    Combination Products Registration

    During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.
  • 51 Request Info

    Webinar on What Is a HIPAA Security Incident, and What Should You Do About It?

    In this webinar you will learn what a HIPAA security incident is and elements you need to have in your security incident report and response policy and procedure. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 52 Request Info

    Webinar on Medical Device Compliance with MEDDEV 2.7.1 Rev 4 for Clinical Evaluation / CER Reporting

    Join this training to examine the clinical data and literature review requirements found in MEDDEV 2.7.1 revision 4 to ensure CERs to meet notified body expectations. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 53 Request Info

    How to be efficient and compliant with 21 CFR Part 11, data integrity, and SaaS/Cloud

    Understand what is expected in 21 CFR Part 11 and Annex 11 inspections Avoid 483 and Warning Letters Learn how to buy COTS software and qualify vendors. Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds Requirements for local, SaaS, and cloud hosting How to select resources and manage validation projects "Right size" change control methods that allows quick and safe system evolution Minimize the validation documentation to reduce costs without increasing regulatory or business risk Write test cases that trace to elements of risk management Protect intellectual property and keep electronic records safe
  • 54 Request Info

    Software Risk Management

    The seminar will address the specific challenges software poses for the risk management process. Basic risk management concepts will be introduced and then applied to software specific applications.
  • 55 Request Info

    GxP/GMP and its Consequences for Quality Management, Quality Audit, Documentation, and Information Technology Systems

    This seminar also includes very important GMP requirements for information technology and how computer systems including documentation management systems must meet GxP/GMP requirements. There is also a review of change control procedure and how it should be used in GxP/GMP environment. GMP regulations require that all documentation be issued, managed, and controlled using a document management system. This seminar also includes information about few major document management systems.
  • 56 Request Info

    Quality by Design - Essential Techniques for Medical Devices

    Using interactive discussion and exercises, students will understand the regulations, context, and history of Design Controls. They will learn how to use Design Control as a tool to ensure product quality while meeting business needs for speed to market. They will come away with key concepts, practice in these concepts, and extensive course notes for future use and reference: Expectations Regulations and History Design Control process, procedures, forms, records, files Linkages to the rest of your Quality Management System Lessons Learned Myths Challenges Best Practices Inspection Readiness
  • 57 Request Info

    Webinar on HIPAA Designed for the Front Office Staff

    Learn the best practices to maintain compliance with HIPAA, what are the penalties for violating the rules and how to handle a HIPAA audit. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 58 Request Info

    Webinar on Risk Based Clinical Trial Monitoring

    Join this webinar to learn the new requirements for risk based monitoring in clinical trials. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 59 Request Info

    Webinar on Successful 510(k) Documentation for Software or Software Containing Medical Devices

    This course is essential for medical device companies interested in submitting software enabled medical devices to the FDA for 510K approval. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 60 Request Info

    Webinar on The Problem of Bacterial Spores and Sporicidal Disinfection

    Join this webinar that outlines the origins and risks of spores, strategies to reduce incidents and incorporation of sporicidal agents into the contamination control program. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link