Best Practices for Medical Device Industry: An Exclusive Set of 16 Webinars

These sets of trainings will help you get familiar with various areas of Medical device industry. This will contain how to minimize risks by applying practical strategies to comply with the currently applicable, relevant laws and regulations governing medical devices, further streamlining the regulatory process using case studies and examples.
Instructor: David Lim, Jeff Kasoff, Mark Swanson, Dev Raheja, Susanne Manz, Natalie Abts, Angela Bazigos, Howard T Cooper, Betty Lane, Mukesh Kumar
Product ID: PACK70065
Webinar Topics Included:
1. 510(k) Submission: Contents and Format for Medical Devices
A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device) as described in 21 CFR 807.92(a)(3).

Objectives of the Presentation:
  • FDA regulations applicable to a 510(k) submission
  • 510(k) program and recent changes in the 510(k) program
  • 510(k) regulatory requirements
  • 510(k) submission requirements for medical devices and in vitro diagnostic devices
  • List of applicable FDA guidance documents
  • List of applicable reference standards
  • Systematic methods to increase 510(k) submission quality
  • Formatting a 510(k) for submission
  • 510(k) contents for medical devices and in vitro diagnostic devices
  • Instructor’s unique practical and actionable strategy
  • CAC-SI method
Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.
2. Best Practices for Purchasing and Supplier Controls in the Medical Device Industry
This presentation will review the QSR and ISO requirements for supplier evaluation and assessment, and provide cost efficient, equally compliant options to many of the most common practices.

Objectives of the Presentation:
  • QSR and ISO 13485 requirements for supplier selection and assessment
  • How to qualify new suppliers in a cost efficient manner
  • How to assess current suppliers in a cost efficient manner
  • How to perform supplier-related corrective action
  • Minimum documentation requirements for supplier qualification, assessment, and related corrective action
Instructor Profile:
Jeff Kasoff, RAC, CMQ/OE, LBB is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management.
3. Establishing a Medical Device Reporting System Integrated with a UDI System
This webinar is intended to help you get familiar with the Medical Device Reporting (MDR) pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act). This webinar is aimed at helping device industry accurately interpret how to establish MDR procedures and further provide practical, actionable and sustainable perspectives with improved awareness and familiarity of the applicable regulatory requirements including UDI system integration.

Objectives of the Presentation:
  • Overview of Relevant Laws and Regulations
  • Definitions
  • Regulatory Requirements for MDR Procedures
  • How to Report A Medical Device Problem (MDR)
  • Reporting Requirements for the User Facilities, Manufacturers, and Importers
  • Relationships with Adverse Event Reporting Systems in EU and Health Canada
  • UDI System Integration
  • Enforcements: Case Studies
  • Conclusion
Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.
4. Update: Medical Device Laws and Regulations in China, Hong Kong, Japan and Korea
This webinar is intended to help you get familiar with medical device laws and regulations in Asian countries: China, Hong Kong, Japan, and Korea.

Objectives of the Presentation:
  • Updated medical device laws and regulations in China, Hong Kong, Japan and Korea
  • Definitions
  • Device classification and rules
  • Regulatory framework for medical devices in China, Hong Kong, Japan and Korea
  • Regulatory requirements for medical devices including in vitro diagnostic devices in China, Hong Kong, Japan and Korea
  • Regulatory requirements for medical devices in China, Hong Kona, Japan and Korea
  • How to establish and maintain systematic methods to meet the regulatory requirements
  • How to streamline the regulatory process
  • Speaker's suggestions for best practices in a PASS-IT manner
  • Conclusion
Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner
5. ISO 13485:2016 - What's Changing and What It Means for Medical Device Companies
This webinar focuses on what quality managers, quality system engineers, quality auditors and other personnel involved in quality system implementation will want to know about the upcoming revision and strategies of ISO 13485.

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.
6. Software FMEA for Medical Devices
Understanding system failures in advance and evidence based best software practices is a profound knowledge. This tool predicts many life cycle failures; assess risk of each failure, and helps design out risks by using the best practices in risk mitigation strategies.

Objectives of the Presentation:
  • ISO 14971 requirements for FMEA
  • Difference between software FMEA and hardware FMEA
  • How can we apply FMEA to software design?
  • FMEA at several levels of software
  • Predicting software malfunctions and failures
  • Applying risk acceptance criteria
  • Failure avoidance strategies
  • FDA requirements for software design control
  • Role of management in software design
Instructor Profile:
Dev Raheja, MS, CSP author of the books Safer Hospital Care and Preventing Medical Device Recalls, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years.
7. Complaint Handling and Medical Device Reporting
It is vital to have efficient and effective processes for managing, analyzing, trending, and reporting product problems. This webinar will cover the basics of complaint management and medical device reporting.

Objectives of the Presentation:
  • Understand regulations and expectations
  • Review enforcement case studies for lessons learned
  • Determine needed processes and procedures
  • Identify best practices
  • Understand the linkage between complaints, investigations, MDR reports, and CAPA
  • Preparing a plan for inspection readiness
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.
8. Applying Human Factors and Usability Engineering Throughout the Medical Device Development Lifecycle
This session will describe techniques that, when applied appropriately, can greatly impact product safety and usability. Product developers looking to maximize safety, usability, and satisfaction with their products, as well as human factors engineers who want to help developers to accomplish this, will benefit from this course.

Objectives of the Presentation:
  • Identifying human factors activities at all stages of development
  • How to properly execute different types of human factors tasks
  • When to employ different techniques to assess a device
  • When and how to consult different types of experts for feedback (e.g. device users, human factors specialists, subject matter experts)
  • How early-stage activities contribute to meeting FDA expectations
  • How to translate feedback and results into design inputs
Instructor Profile:
Natalie is the Program Manager for the Usability Services division of the National Center for Human Factors in Healthcare. She oversees the technical and quality aspects of usability projects conducted both for the medical device industry and within MedStar Health.
9. FDA Guidance Design Considerations for Pivotal Clinical Investigations for Medical Devices
This webinar introduces FDA’s guidance "Design Considerations for Pivotal Clinical Investigations in Medical Devices" that was published in late 2013. It discusses the regulatory considerations for clinical study design, and delves into the issues of bias and variance that may impact the quality of the data obtained in the study, as well as the interpretation of the data.

Objectives of the Presentation:
  • The Guidance
  • General Principles
  • Some Principles for the Choice of Clinical Study Design
  • Clinical Outcome Studies
  • Diagnostic Clinical Performance Studies
  • Sustaining the Quality of Clinical Studies
  • Summary
  • Q&A
Instructor Profile:
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.
10. Auditing, Qualifying and Controlling, Suppliers and Contractors for Pharmaceuticals and Medical Devices (Purchasing Controls)
This webinar will help you understand the entire lifecycle of suppliers and contractors regardless of whatever your experience level is. You will gain an understanding of the processes; you can compare your processes to the processes described in this webinar. You’ll see the strengths and weaknesses of your own processes so that you may build on the strengths and improve the weaknesses. The result will be a more effective operation.

Objectives of the Presentation:
  • To clearly define the regulatory requirements for incoming material controls and suppliers/contractors
  • To introduce quality concepts and principles outside the regulations that improves supplier/contractor control and effectiveness
  • To provide a perspective on the FDA guidance “Contract Manufacturing Arrangements for Drugs: Quality Agreements”, May-2013
  • To enhance the understanding of the supplier-contractor lifecycle by using flowcharts describing the logical inputs and outputs of the process
  • To describe the “What & How” for establishing a program for effectively controlling suppliers and contractors
Instructor Profile:
Howard T Cooper has over 40 years’ experience managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, nutraceutical, & food industries.
11. Medical Device Employee Training - Requirements and Implementation Tips
This presentation will provide information and tips on best practices for assuring your employees are properly trained. Improperly or inadequately trained employees lead to both product and process nonconformities.

Objectives of the Presentation:
  • Review of the types of training requirements from the FDA and ISO 13485
  • Providing examples of ways to document training needs for employees
  • Looking at various ways to monitor the effectiveness of each type of training
  • Provide examples of simple spreadsheets that can be used to track training needs and records in one file. These are ideal for small and medium sized companies
  • Overview of types of solutions that can be applied to larger medical device companies
  • Description of specific techniques for monitoring and documenting training effectiveness
Instructor Profile:
Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. Her background in digital systems engineering enables her to facilitate design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.
12. Points of Consideration during Medical Device Design and Development - Dos and Don’ts
This webinar is intended to discuss important aspects of medical device design and development. Under the Federal Food, Drug, and Cosmetic Act (FD & C Act or the Act), a medical device firm is subject to design control requirements, to the extent applicable during development including clinical trials and post-marketing. Based on the FDA enforcement trends, design control failure are frequently cited in 483s and FDA warning letters.

Objectives of the Presentation:
  • Statutes and Regulations
  • Device Design Concept
  • Definitions
  • Design and Development Planning
  • Key Considerations
  • Design Control System Components
  • Design Control Sub-Systems
  • Design Input and Design Output
  • Design Review
  • Design V and/or V
  • Design Transfer and Design Changes
  • Design History File (DHF), Device History Record (DHR) and Device Master Record (DMR)
  • Common Mistakes and How to Avoid
  • How to Prepare for FDA inspection for Design Control
  • Best Practices based on Actual Cases
  • Speaker's Recommendation and Suggestions on PASS-IT Solutions
Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.
13. Software Reliability and Safety Fundamentals for Medical Devices
Software risk analysis is more difficult than hardware analysis because of thousands of interactions within and with other devices. Most manufacturers have not applied rigors of hardware risk analysis to software designs. In this webinar you will learn how to use risk analysis tool on software design, software safety and design for reliability.

Objectives of the Presentation:
  • Learn how to use risk analysis tool on software design
  • Learn the principles of software safety
  • Learn the principles of design for reliability and trustworthiness
  • Learn how to write sound software specifications
  • Safety flaws in the software specifications
  • Writing good safety requirements
  • Writing good reliability requirements
  • Heuristics for designing for trustworthiness
  • Software safety analysis
  • Safety analysis tools
  • Analyzing active safety
  • Safety mitigation methods
  • Designing for software reliability
  • Software Failure Mode and Effects Analysis
  • Fault Tree Analysis for complex mitigations
  • Software qualification testing for safety
  • Software qualification testing for reliability
  • Examples of best practices
Instructor Profile:
Dev Raheja, MS, CSP author of the books Safer Hospital Care and Preventing Medical Device Recalls, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years.
14. Implementing Medical Device Directive (MDD) for CE Mark in EU
This webinar will help you understand the European Union (EU) Medical Device Directive (MDD), which governs medical devices. This webinar is further intended to provide guidance on the regulatory requirements set out in the applicable Directive, which helps to assure that medical devices are safe and effective for their intended use.

Objectives of the Presentation:
  • EU Laws For Medical Devices
  • CE Marking Principles
  • Overview of the European Medical Device Regulations and Regulatory Framework for Medical Devices
  • Medical Device Directive (MDD)
  • Device Classification and Rules
  • 2007/47/EC amending MDD and AIMDD
  • Essential Requirements
  • Technical File: Contents and Format
  • ISO 13485, ISO 14155, and ISO 14971
  • Clinical Evaluation and Clinical Trials
  • GHTF and MEDDEV Guidance Documents
  • Recent Trends and Future Changes
Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.
15. Strategies for 510 (k) Applications for Medical Devices Software
This webinar will provide practical tips and useful suggestions regarding testing requirements and documents to be included in the 510(k) applications for medical device software. Practical strategies for complying with the current rules will be discussed using case studies and examples.

Objectives of the Presentation:
  • FDA definitions for software in medical devices
  • What makes your software a medical device?
  • What specific software –related documentation is required?
  • Risk Assessment/Mitigation for software related risk in medical device operation
  • Software change management and its relationship to risk assessment
  • When is a 510(k) needed for Off the Shelf (OTS) software?
  • Could the Special 510(k) or Abbreviated 510(k) apply to your application?
  • Exemptions to the 510(k) requirements
  • Labeling of Software devices
Instructor Profile:
Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD., who expertise is in developing Global Regulatory Business Strategies for biomedical product development.
16. Implementing FDA - compliant cyber security requirements for premarket submissions of medical devices
This webinar will address the best practices for cyber security management for premarket submission purposes concerning medical devices containing software as well as software that is a medical device. The speaker will walk you through the FDA compliant practices. This training session is further intended to increase our awareness that effective management of cyber security can reduce the risk to patients by reducing the likelihood of compromising cyber security whether it is intentional or unintentional.

Objectives of the Presentation:
  • EU Laws For Medical Devices
  • Definition
  • Principles
  • Cyber security Functions
  • Key Functional Requirements for Cyber security
  • How to Address the Requirements
  • Documentation
  • Relevant and Applicable Standards
  • Best Practices: Do's and Don'ts
  • PASS-IT Recommendations
Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.
How It Works:
  • Recorded sessions will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Links are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Reference materials for Webinar Recording will be mailed to your registered e-mail id
Who will benefit?
  • Purchasing Management
  • Quality Professionals (Associates, Specialists, Managers, Directors or VPs)
  • Compliance Officers, Legal Counsel, Managers and Directors
  • Sales and Marketing Managers, Directors, and VPs
  • Regulatory affairs (associates, specialists, managers, directors or VPs)
  • Quality professionals (associates, specialists, managers, directors or VPs)
  • R&D (engineers, scientists, managers, directors or VPs)
  • Complaint Handling and Risk Management Managers and Site Managers
  • Business Development Managers, Directors, and VPs
  • Medical Device Industry
  • Suppliers to medical device manufacturers
  • Software Development Managers and Engineers
  • Hardware Managers and Engineers
  • Service Engineering Managers and Engineers
  • Individuals participating in Failure Investigations
  • Medical device manufacturers
  • Usability/human factors engineers
  • Design and development engineers
  • Industrial designers
  • Project managers
  • Clinical Trial Physician / Doctor
  • Data Management
  • Data Monitoring
  • Institutional Review Board
  • Human Resources professionals
  • Trainers
  • Clinical affairs (associates, specialists, managers, directors or VPs)
  • Other interested parties
  • Product Development Managers and Engineers
  • Reliability Managers and Engineers
  • Corporate Legal Staff
  • Documentation specialists
  • Medical writers
  • Medical device IT specialists
  • Medical device and 510(k) consultants
  • Import Supervisors
  • Customs Brokers

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