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Courses

  • 41 Request Info

    Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals

    This webinar will discuss requirements and compliance under the applicable FDA regulations for medical device reporting (MDR), recall and reports of corrections and removals in the US. Who Will Benefit: This webinar will be valuable for anyone in global medical device industry including, but not limited to, those working on drugs, biologics and in vitro diagnostic devices who are involved in the processes of adverse event reporting, recall, reports of corrections and removals, complaint handling and regulatory compliance. Instructor Profile: Dr. David Lim, president and principal of Regulatory Doctor, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Note: Use coupon code 232082 and get 10% off on registration.
  • 42 Request Info

    Latest Requirements for Sponsors and Laboratories for Analyzing Clinical Trial Samples to Meet GCP/GCLP Internationally

    This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance. Who Will Benefit: This webinar will provide critical assistance to FDA and EMA regulated companies currently carrying out or preparing to conduct clinical trials for pharmaceutical, biotechnology, and biologics products using clinical laboratories. It will also be applicable to personnel working in clinical laboratories. Clinical development managers and personnel Clinical research associates Clinical research archiving and document management personnel Instructor Profile: Dr. Laura Brown, PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. Note: Use coupon code 232082 and get 10% off on registration.
  • 43 Request Info

    ComplianceOnline Medical Device Summit - 2015

    Innovate novel ideas for advancements in medical device technologies without compromising their safety and effectiveness. This summit brings together some of the renowned R & D experts and technology innovators to share information regarding opportunities, obstacles, best practices and challenges in the development of the new devices. Attendees will get insight into device innovation trends and upcoming changes in the medical device regulations. Why you should attend this summit Future trends of Medical Device Regulation, Risk Management, UDI, recall complaint Management etc. Listen from FDA/CHRH Directors: What is critical to Quality Get update on FDA compliance Listen from Congressman Scott Peters on “Medical Device an inside state perspective” Note: Use coupon code 232082 and get 10% off on registration.
  • 44 Request Info

    Human Factors and Design Controls for Medical Devices and Combination Products: 2-day In-person Seminar

    The course will give the participant the ability to formulate an QMS document and a thorough understanding of verification and validation procedures, The course will also give through guidance in development of Combination products both for the USA and European marketplace from a regulatory and manufacturing point of view. Emphasis will be placed on critical pathways, clinical development and regulatory approval. Who Will Benefit: Drug, device, diagnostics, and biologics regulatory, quality, and clinical professionals involved with combination product development and oversight Product stewards Business development executives involved in combination product strategic partnerships Note: Use coupon code 232082 and get 10% off on registration.
  • 45 Request Info

    Production and Process Control: Building a Robust System for Medical Device Companies: 2-Day In-Person Seminar

    It does if you have the right controls in place - including documented instructions, environmental control, adequate equipment properly installed and maintained, production software that you trust, properly controlled test equipment, and validated processes - and your system implements both FDA QSR and ISO 13485:2003. In this two-day workshop, you will learn the essentials of production and process control. Beyond the essentials, the workshop provides practical methods to help you create a robust system that produces your devices and can withstand a rigorous FDA Inspection. Breakout sessions provide an opportunity to put the lessons into practice. Case studies, based on FDA Warning Letters and the Quality System Inspection Technique (QSIT), provide an opportunity to learn from the experience of other companies. Note: Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.
  • 46 Request Info

    Designing Effective and Efficient Extractables or Leachables Studies for Biologics

    Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study. Who Will Benefit: R&D Laboratory personnel R&D Laboratory Supervisors and Management QC Laboratory personnel and management Protein Formulation Group personnel and Management Regulatory Affairs personnel Instructor Profile: Dr. Subbarao, received her Ph.D. in Bio-organic Chemistry from the Indian Institute of Technology, Bombay, India. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. Note: Use coupon code 232082 and get 10% off on registration. For Registration: http://www.complianceonline.com/how-to-comply-with-recent-expectations-for-extractables-leachables-testing-for-biologics-webinar-training-701591-prdw?channel=am_trainingregistry
  • 47 Request Info

    Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment

    This training program will discuss the guidance issued by the FDA on December 11, 2014, “Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.” The new guidance replaces a guidance with the same title that was earlier issued on August 21, 2008. Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Regulatory management or staff involved with regulatory filings Project management Product development managers or project managers Instructor Profile: Cheryl Wagoner has 20 years of experience in quality assurance, and regulatory affairs. Note: Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015. For Registration: http://www.complianceonline.com/safety-and-compatibility-of-passive-implants-in-the-magnetic-resonance-environment-webinar-training-704141-prdw?channel=am_trainingregistry
  • 48 Request Info

    Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

    This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices. Who Will Benefit: Design Engineers QA Managers Quality Engineers Regulatory Affairs Managers Manufacturing Engineers Instructor Profile: John Chapman, BS, MBA, RAC has over 35 years’ medical device regulatory experience and over 15 years’ experience with the European Union’s medical device directive, 93/42/EEC. Note: Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.
  • 49 Request Info

    Understanding and Implementing the EU Vigilance System

    This training program will furnish attendees with an overview of the EU vigilance system and the understanding and tools necessary for effective QMS implementation. It will also provide an implementation checklist for the vigilance system. Who Will Benefit: Regulatory Managers Management Representatives Quality Managers Compliance Managers Notified Body Liaison 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 NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.
  • 50 Request Info

    Technology Transfer and Validation for Medical Devices and Pharmaceuticals: The Link between Development, Validation and Commercial Production

    The parallel requirements for medical devices and pharmaceuticals are incorporated into this comprehensive webinar that delineates the foundation for technology transfer and validation, encompassing regulatory requirements and voluntary guidance. Who Will Benefit: This webinar will be of interest to professionals in early or middle phase in their careers in research and development, product development, manufacturing or validation in the pharmaceutical or medical device industries. Professionals interested in a refresher course on the concepts of technology transfer and validation will also benefit. Participants will include: Quality Engineers Manufacturing Engineers Validation Engineers Instructor Profile: Carlos A. Rodriguez-Garcia, PhD, ASQ CSSGB, CBA, is president of BioMed Pharma Consulting, LLC, an independent consulting firm providing services in quality management systems to the pharmaceutical and medical device industries.
  • 51 Request Info

    Writing Effective Clinical Evaluation Reports as Part of Post-Market Surveillance

    This medical device webinar will discuss strategies for meeting the Post Market Surveillance requirements as described in Annex X of the MDD (MDD 93/42/EEC, updated per the 2007/47/EEC M5 amendment, Annex 1: Essential Requirements), MEDDEV 2.7.1, Dec 2009 and ISO 14155. Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Medical device QA managers Regulatory affairs professionals Clinical managers or project managers Instructor Profile: Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Note: Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.
  • 52 Request Info

    Compliant Clinical Research Conduct: What Every Clinical Research Professional Needs to Know

    The many regulatory agencies charged with oversight of Clinical Research have exacting requirements to ensure the protection of study participants; and while there is overlap in goals there are differences in expectations and standards. The complex regulatory environment can be difficult to navigate, but understanding it is a necessity for all clinical research professionals. Compliance with all of the various regulatory requirements ensures safety of patients, quality of data and timeliness and efficiency of study completion. Who will Benefit: Healthcare providers interested in exploring the field of Clinical Research New Clinical Research Coordinators (1-2 years) New Principal Investigators Note: Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.
  • 53 Request Info

    Understanding and Implementing the Medical Device Directive

    Course Description: Note: The EU intends to replace the current directives on medical devices with a set of regulations. The negotiations are ongoing and behind schedule. This seminar covers the directives, but provides also provides information on the proposed regulations. Medical devices marketed in the European Union must follow the Medical Device Directive (MDD); IVD device and active implantable devices have other directives. The MDD can be complicated, especially for US companies, because the MDD’s approach is different from the regulatory approach in the US. Who will Benefit: This course benefits anyone involved in quality or regulatory compliance for medical devices marketed in the European Union and is ideal for quality, regulatory, and clinical professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. Regulatory Managers Quality Managers and Directors Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 54 Request Info

    3rd Annual ComplianceOnline Medical Device Summit 2017

    Why you should attend this summit Future trends of Medical Device Regulation, Risk Management, UDI, recall complaint Management etc. Listen from FDA/CDRH Directors: What is critical to Quality Get update on FDA compliance Learn more about Medical Device Single Audit Program (MDSAP) and Other Third Party Programs Explore upcoming changes in global regulation Supply Chain Optimization Criteria for Medical Device commercialization success Panel Discussion Advanced Technology How to choose Vendors/Suppliers Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 55 Request Info

    Navigating the Maze for Post-Market Compliance -- Complaint Handling, MDRs, Recalls and Proposed Guidance on FDA Risk Benefits: One and a Half-day In-

    This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years’ experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions. Learning Objectives: Understand how to comply with complicated Compliant Handling, MDR and Recall requirements. Firms MDR reporting and FDA's handling of reports. Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA. Minimize your risk of regulatory enforcement actions. Assist with the creation and maintenance of effective procedures for handling complaints, reportable events and recalls. Who will Benefit: This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting. Regulatory Affairs QA/QC Project Managers Regulatory Professional Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 56 Request Info

    Australian Regulatory Guidelines for Medical Devices (ARGMD): Government Reimbursement, Requirements, Fees and Turnaround Time to Product Approval: 2-

    The Australian regulatory and reimbursement agency have particular requirements in their assessments of applications for Medical Devices intended for supply in Australia. A well-defined approach or a clearly set up manual is nonexistent but the expectations are clear, if the application has errors or a document is not conclusive than the assessment of the associated application is delayed or worse still, the complete submission may just be rejected. You may then need to start again and potentially lose your fees. Who will Benefit: This course is designed for people tasked with submitting applications to the Regulatory or the Reimbursement Government Authority for Medical Devices (Exclusion are IVD products). Personnel in the following areas will benefit from the course: Personnel involved in start-up or in well-established global companies with intentions to market their products in Australia Regulatory professionals Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 57 Request Info

    Implementing the New Usability Engineering Standard

    Usability Engineering has become a major topic. The current standard tightens the linkage to risk management. In addition, there are changes in the US and EU approach, all of which find a basis in this standard. Attending this presentation provides the information you need to prepare for these major changes. Who Will Benefit: This presentation supports all medical device companies engaged in design and risk management. The implementation requires coordination across many areas including: Design Engineering Managers Interface designers, including software engineers Technical writers providing instructions for users Usability engineers Risk managers Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 58 Request Info

    Overview of Changes in ISO 13485: 2016

    This training program will discuss changes from ISO 13485: 2003 to ISO 13485: 2016. Attendees will learn how to apply additional supplier controls and understand how improvement and corrective action clauses are strengthened. Who Will Benefit: Quality System Associates and Managers Regulatory Affairs Associates and Managers Supply Chain Professionals Instructor Profile: Lena Cordie has over 20 years of quality and project management experience including 10 years in project management at Target Financial Services and 11 years as director of operations at Key Surgical, a medical device company focused on sterile processing, personal protection, and OR products. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 59 Request Info

    Supplier and Service Provider Controls: FDA Expectations

    This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address. Who Will Benefit: Regulatory Compliance Professionals Quality Assurance Professionals Quality Control Professionals Supply Chain Personnel Regulatory Affairs Professionals Instructor Profile: Vanessa Lopez is senior principle quality, and a regulatory and compliance consultant. She has held a wide variety of leadership roles in the medical device (Class: I, II, and III), pharmaceutical (API; finished product) and environmental regulated industries as well as the consulting services industry. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 60 Request Info

    You have a BI Positive or Product Sterility Positive - Now What?

    This webinar will discuss what actions should be taken following a positive result in a sterility test on a biological indicator (BI) during performance qualification or routine testing. It will also explain the various items that should be investigated to determine the root cause and the follow up to the investigation. Who Will Benefit: This webinar will provide valuable information to all companies that produce sterile medical devices. The following personnel will benefit: QA personnel Validation specialists Manufacturing personnel involved in validations R&D specialists 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.