ISO Standards Applicable for Medical Devices: 8 Courses You Should not Miss

ISO Standards serve a very important role in the device industry because they encourage consistency, enhance safety and improve efficiency. While their use is voluntary, companies employ them to their advantage and do not think of them as a burden. The ISO 13485 standard is the sector quality management standard for medical device organizations. The ISO 10004:2012 model has four major elements in the customer satisfaction process: Identifying customer expectations, gathering data, analyzing the data, and communicating the information. ISO 11135 for sterilization using ethylene oxide, and ISO 14971 has long been the gold standard of risk management for medical device companies. This package training will provide the attendees with an in-depth knowledge of all these regulations and their most modern updates.
Instructor: Mark Swanson, Meena Chettiar, Dennis L. Gorectke, Daniel O'Leary, Mark Roberts, Mercedes Massana, David Amor, Betty Lane
Product ID: PACK70044

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Suppliers to medical device manufacturers
  • Quality and Regulatory Managers
  • Sales Managers, Marketing Managers
  • Project Managers
  • Complaint Handling MDR Specialists
  • Data Analysts
  • Medical Device and IVD Manufacturers
  • Microbiology
  • Sterilization Specialist
  • Risk Managers
  • Systems engineers responsible for developing requirements
  • Software Developers
  • Test Engineers
  • Directors, VPs
  • Quality auditors, Internal auditors ,Quality engineers

Webinars included in the Package:

ISO 13485:2016 - What's Changing and What It Means for Medical Device Companies(Duration: 90 Minutes)

In this webinar, a member of the ISO working group (Mark Swanson) will present an overview of the significant changes coming in this revision along with interpretations gleaned from the working group meetings on the reasons driving the change, the application of risk management throughout the product life-cycle and other updates in the requirements along with the likely timeline for implementation of the revision.

Objectives of the Presentation:

  • Understand the general use of ISO 13485 standard
  • Understand the reasons driving the changes to ISO 13485 for this third revision
  • Understand what is changing in ISO 13485
  • Understand how these changes affect an organization involved in the medical device industry
  • Be able to use the content to implement the required changes in an organization to obtain or maintain a quality certification
  • Determine other considerations for obtaining or maintaining a certification for an ISO 13485 quality system

Instructor Profile:

Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and lead consultant of H&M Consulting Group, a group focusing on helping small to mid-sized companies having the same regulatory and quality systems knowledge as the large medical device companies. In addition to this, Mark is also the Director of the Medical Technology Quality Graduate program at St. Cloud State University.

Understanding ISO 13485: 2015 Requirements for Medical Devices(Duration: 75 minutes)

The speaker will provide the background behind ISO 13485: 2015 and identify all areas that are being changed from the current ISO 13485: 2003 requirements for medical devices manufacturers. Steps involved in updating your current quality system to fulfill the updated quality requirements will be discussed. Timelines for compliance to the new standard and recommended steps will be clearly identified for the audience.

Objectives of the Presentation:

  • What is in store for currently marketed medical devices when ISO 13485: 2015 gets launched?
  • Which areas are being revamped under ISO 13485: 2015?
  • Where does one begin?
  • What sort of gap analysis is a must?
  • When is your quality system expected to be completely switched over to cater to the changes being introduced?

Instructor Profile:

Meena Chettiar Meena is currently working as a Quality and Regulatory Manager at ProMed Pharma, Medical and combination device manufacturer.Meena has played a key role in quality system implementations in the food, pharmaceutical, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US and abroad. Meena is the Vice chair of member development for MNASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence).

ISO 13485 and Regulatory Affairs Training(Duration: 90 minutes)

The Webinar will extensively cover comparison of various QMS Objectives, Objective of ISO 13485:2003, how to set out requirements for a QMS that is capable of consistently meeting customer requirements, including regulatory requirements. The speaker will also speak about the objectives of ISO 9001:2008 and how to set our requirements for a voluntary, generic QMS that is capable of meetings customer & Regulatory requirements, and enhancing customer satisfaction through processes including continual improvement.

Objectives of the Presentation:

  • Management Review
  • Document Control
  • Internal Audit
  • Control of Nonconformance
  • Corrective & Preventive Action

Instructor Profile:

Dennis L. Gorectke has an entrepreneurial spirit having Run ISO Documents & Six-Sigma Consultants very successfully since 1992. He did ISO 9001 Training for the SBDC and UW Whitewater for five Years. He has worked for the Corporate Headquarters Quality Departments of Harley-Davidson Company, Johnson Controls and the Ford Fairlane Training & Development Center in Dearborn Michigan. All these Positions were as a Consultant & Trainer.

Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012(Duration: 90 minutes)

ISO 10004:2012 provides a model for determining customer satisfaction. This webinar describes the model, and puts it into the context of manufacturing medical devices. For example, the webinar explains the difference between a complaint in the regulatory realm and a complaint involving only customer satisfaction. Attend this webinar to understand the four major elements in the customer satisfaction process in ISO 10004:2012 model.

Objectives of the Presentation:

  • The requirements in a QMS
  • The difference between a complaint in each system
  • Methods to identify customer expectations
  • An explanation of the Kano model to characterize expectations
  • Methods to collect customer satisfaction data
  • An explanation of different survey methods and their applications
  • Techniques to analyze customer satisfaction data
  • Communicating customer satisfaction data
  • Issues related to Management Review
  • Using Preventive Action for improvement

Instructor Profile:

Daniel O'Leary is the 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. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.

Changes to Ethylene Oxide sterilization in the new ISO 11135:2014 (Duration: 60 minutes)

ISO 11135:2014 is already recognized by the FDA and will be harmonized for the rest of the world in the next 3 years. Changes have impact on your validations, revalidations and routine process control. This presentation will let you understand the changes and determine the impact on your sterilization processes.

Objectives of the Presentation:

  • Understand the timing of the change
  • Determine what to expect from your contract sterilizer
  • Determine impact of the changes on your validation/revalidation
  • How to prepare an action plan to implement the changes
  • Find out if there will be any impact on routine sterilization processes

Instructor Profile:

Mark Roberts is the head of Roberts Consulting and Engineering (RCE), a consulting firm specializing in quality system and sterility assurance compliance. He was previously the Manager for the Western US for TUV SUD Product Service. He is an accredited lead auditor and notified body auditor. He still performs audits and product/sterilization file reviews for notified bodies on a contract basis. He has 30 years of experience in the medical device industry.

An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971 (Duration: 75 minutes)

ISO 14971 Medical devices - Application of risk management to medical devices is a voluntary standard that medical device manufacturers should incorporate into their design and development process in order to ensure medical devices designed are safe and effective. The FDA now also recognizes ISO14971, and can audit to it if manufacturer's claim they conform to it. Although ISO 14971 has been in place since 1998, many companies still find it difficult to properly interpret the requirements of the standards and having a risk management process which is not helpful in designing robust, safe medical devices.

Objectives of the Presentation:

  • How are risk management activities integrated throughout the development process
  • The roles that Hazard Analysis, FTA, FMEA, HAZOP and PFMEA play in an Integrated Risk Management Process
  • How to control and verify risk mitigations
  • How to perform a Risk Benefit Analysis
  • The importance of maintaining Risk Management documents in the Post Production era
  • What information to include in the Risk Management Plan and Report for better auditability
  • How to integrate Risk Management with CAPA, Complaints and Non-Conformance processes

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 thirty years of experience in the Medical Device industry; Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems.

Understanding ISO 14971:2012: Changes to Annex Z and Impact on the Risk Management File(Duration: 60 minutes)

ISO 14971 has long been the gold standard of risk management for medical device companies. Recently, several changes to Annex Z have been implemented in the 2012 revision which otherwise may go unnoticed but which have significant impact to the risk management file. Learn about the discontinued support of the ALARP principle and how to address negligible risks, new requirements surrounding risk benefit analyses and mitigation strategies for risks that don't include labeling. This discussion will use case studies to create a practical approach to modifying or creating your risk management file.

Objectives of the Presentation:

  • Highlight key changes to ISO 14971:2012
  • Review Annex Z change impact to current risk management strategies
  • Learn how to update your risk management file to comply
  • Review case studies of real examples

Instructor Profile:

David Amor is a medical device consultant, having worked with companies such as Boston Scientific, St. Jude Medical and Hospira in helping develop quality management systems and product development infrastructures. A graduate of the Senior Innovation Fellows program at the University of Minnesota Medical Device Center, David was named a Top 40 under 40 Medical Device Innovator in 2012 and founded MEDgineering, a niche quality consulting firm focusing on FDA remediation and remote work solutions.

Efficient and Effective FDA and ISO Management Reviews (Duration: 60 minutes)

Are your management reviews effective or do you have trouble getting senior management engaged? Perhaps you are not using an effective approach that fits your company or your management. It is not only important to know what must be covered, but how to present this information to your management team. Learn how to get management's attention to the information being presented and how to make it fit your company culture. Obtain practical information on conducting and documenting management reviews.

Objectives of the Presentation:

  • Understand the requirements of Management Review
  • How to get Senior Management Buy-In
  • Making Management Reviews effective
  • Making Management Review fit your company culture
  • Place in Risk management
  • Conduct a Management Review

Instructor Profile:

Betty Lane has over 30 years' experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well quality system requirements for other area such as Europe and Canada.

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