US Medical Device & Quality System Regulations - Design Controls & Validation

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    "This course was great! I enjoyed it a lot and thanks to the Course Director for the great discussions and sharing his expertise."


    Valentin P., GMP Compliance Auditor, F. Hoffmann - La Roche

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    "Exceeded my expectations relative to courses I’ve taken from other providers. I particularly enjoyed the knowledge and experience of the Course Director and his presentation skills level."  


    Amir S., Design Quality Engineer, Zimmer Biomet

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    "This was a really good course and I learned a great deal. I appreciated the fine examples and patience of the course director." 


    Ivan V., NPI / Automation Superintendent, NxStage-MediMexico

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    "This course director has an extensive fund of knowledge and experience in regulatory affairs, clinical research and compliance, which he communicates very effectively to course attendees. He has enabled me and inspired me to pay greater attention to detail in the course of my clinical research activities as a multi-center trial P.I. than ever before. Thank you!"


    Dr. Alexander S., Colonel, US Army

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Course Director

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Course Fee

$2650.00 Regular Registration

$2450.00 Early Bird Pricing (Register 30 Days in Advance)

Course Description

This course focuses on introducing the students to the regulatory requirements stipulated under the US Medical Device Quality Systems Regulation. Each of the seven key elements of Design Control compliance will be briefly reviewed. In addition, specific GMP requirements, submission dossier preparation throughout the Design Control lifecycle and submission strategy will be discussed.


This course is US-focused. The students will gain a fundamental understanding of how medical devices are regulated in the US: the main legal basis, FFDCA (21 U.S.C. 301), the specific Medical Device Quality Systems Regulation and the comparison/contrast of the GMP requirements imposed on the medical devices and pharmaceutical products in the US. In addition, the students will be introduced to a brief overview of relevant global regulatory framework including the EU MDR 2017/745 and key ISO standards including ISO 13485:2016 and ISO 14971:2019.

 

There are seven major building blocks for the Design Control of medical devices, outlined by the FDA and based on the Quality System regulation: User needs, Design inputs, Design process, Design outputs, Design verification & validation, and Design Review. This course covers all aspects of these seven building blocks for the purpose of providing the students with a clear picture of the entire design control process and corresponding regulatory compliance requirements. Discussion topics are centered on proper translation from the initial user needs to the final design outputs, timing and essential elements of Verification vs. Validation for effective transfer for commercialization. Particular attention is paid to risk considerations and how to properly conduct risk analysis and then manage the risks.

Who Should Attend

This 20 hour course will be most valuable to medical device industry engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers needing a comprehensive understanding of US laws governing medical devices and relevant device quality system regulations, in particular, all essential elements of Design Controls, Design Inputs/Outputs, Human Factors, Design Validation/Verification and Risk Management.

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  • Learning Objectives

    Upon completion of this course, the participants will be able to:


    • Describe the legal basis & industrial standards regulating the manufacture of medical devices
    • Gain an understanding of the regulatory framework for Design Controls and recommendations to effectively meet the requirements of Design Controls 
    • Describe general regulatory requirements pertaining to design controls within the quality system and regulation, design control procedures, safety/risk management, documentation, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design controls
    • Outline steps and tools to establish and implement effective design controls and  quality management system
    • Gain an understanding of the framework for Design V&V, Risk Analysis and recommendations to effectively implement their quality system and meet the regulatory requirements
    • Describe general regulatory requirements pertaining to design verification & validation, safety/risk management, methodology, documentation, and planning strategies for integrating risk management
    • Outline steps and tools to establish and implement effective risk management and quality management system

  • Agenda


    Section 1: Introductions to US Medical devices Regulation (MDR)

    • The Market
    • The Law
    1. Device Classification
    2. Regulatory Oversight & Compliance
    3. Regulatory Submissions Essentials

    Section 2: Quality System Regulation

    • Global Quality System Overview
    • Pharmaceutical quality system framework in the US
    • Medical Devices Specifics in the US
    • Pharmaceuticals vs. Medical Devices

    Section 3: Design Control Basics I

    • Design Process Planning
    • User Needs
    • Design Inputs/Outputs

    Section 4: Design Control Basics II

    • Human Factors

    Section 5: Design Control Basics III

    • Introduction to Design Verification & Validation
    • Design V&V Planning
    • Design Verification vs. Validation
    • Design Verification Basics
    • Design Validation Basics
    • Human Factors Validation

    Section 6: Design Control Basics

    • Documentation/Traceability
    • Design Transfer
    • Summary

    Section 7: Risk Management (RM)

    • Regulatory & ISO guidelines
    • Hazard vs. Risk:  definitions & examples
    • Risk management guidance
    • Risk management tools

    Section 8: Risk Analysis (RA)

    • RA scope
    • RA techniques & tools

    Section 9: Design Control Class Exercise


    Section 10: Select Topics

    • FDA risk/benefit analysis & decision-making
    • FDA biocompatibility risk management

    Section 11: Select Topics

    • Cybersecurity
    • Software validation
    • Reused MD cleaning validation

    Section 12: Case Studies


    Recap, Review and Q&A


  • Testimonials

    “This was the best course I've taken in regard to Medical Devices.  I enjoyed the depth at which risk, validation and verification were discussed.”

    James, Product Engineer, Coltene


    “This course was great! I enjoyed it a lot and thanks to the Course Director for the great discussions and sharing their expertise.”

    Valentin P., GMP Compliance Auditor, Roche


    "The Course Director provided real life applications and examples and was open to any and all questions. Course director presented information in a clear and concise fashion. In addition, the presentation from the course director and small group setting made it easy to ask questions."

    Becky W., QA & RA Director, Avero Diagnostics


    “This was the first course I have taken and was very impressed. I really enjoyed the instructor and how she engaged us. It was definitely an overview of V&V, but it helped calling out the specific regulations/guidance to follow in the process, and understanding what elements are most important.”

    Anne M., Regulatory Compliance Analyst, Fujirebio Diagnostics


    “The course was very informative and completely covered the course agenda.  CfPIE always provides extra material which I find very useful.”

    Hector D., Principal Product Mgmt. Engineer, Ethicon


    “The course director had the best experience and expertise in this subject I’ve seen for conducting this type of training.”

    Alberto R., Sustaining Engineering, NxStage-MediMexico


    “This was a really good course and I learned a great deal.  I appreciated the fine examples and patience of the course director.”

    Ivan V., NPI / Automation Superintendent, NxStage-MediMexico


    “This was much more in-depth than other courses I've attended.  The class exercises were great for reinforcing the material.”

    Jessica P., Senior Engineer, Terumo Cardiovascular


    “It was very helpful to go through the MAUDE database to gather risk information for different product codes. This information is helpful to ensure that you are mitigating appropriately risks that are real for your product.”

    Scott V., Senior Development Engineer, Zimmer Biomet


    “Exceeded my expectations relative to courses I’ve taken from other providers.  I particularly enjoyed the knowledge and experience of the Course Director and their presentation skills level.”

    Amir S., Design Quality Engineer, Zimmer Biomet


    “Very good course. I learned a great deal about practical uses of quality related engineering.  I was able to ask questions that were specific to the work I do.”

    Sara A., Design Quality Engineer, Zimmer Biomet


    “The instructor had good depth and breadth of knowledge and presented it very well.  A great introduction to the course material.”

    Dan C., V & V Research Engineer, Kardium


    “The course was fantastic.  It was the best Medical Device Course I have attended.”

    David H., Clinical Trials Coordinator, Cook Biotech


     “The course was very informative.  The course director was well informed and conveyed a wealth of experience in the practical application of course material.”

    Alastair R., Doctor, D3 Technologies


    “This course was very beneficial and went into more detail that I expected.  The real-life examples were great.  The instructor did a nice job of keeping the class engaged and attentive.  This was a useful course and I would recommend it.”

    Jennie R., Clinical Research Associate, Ocular Therapeutics


    “This course director has an extensive fund of knowledge and experience in regulatory affairs, clinical research and compliance, which they communicate very effectively to course attendees.  The course director has enabled me and inspired me to pay greater attention to detail in the course of my clinical research activities as a multi-center trial P.I. than ever before.  Thank you!”

    Dr. Alexander S., Colonel, US Army


    “The instructor did an excellent demonstration of validation versus verification.  The instructor took a myriad of questions from attendees with significantly different knowledge bases and answered them thoughtfully and with excellent real-life examples.”

    Anthony G., Validation Manager, BioMimetic


    “Great course filled with so much useable information.”

    Lynn C., QA Manager, Stemcell Technologies


    “The course director showed their breadth of knowledge by providing examples and background on demand on all the topics we covered.  They specifically helped me with practical guidelines for my ‘task at hand’.  This was a valuable class!”

    Richard P., Software Developer


    “Excellent course!  The Course Director was extremely knowledgeable and excellent delivery of course material.”

    Andrew H., QA Group Leader, Advanced Medical Solutions


    "All of the course content was very good as it reflected what is carried out in my organization." 

    Jonathan F., Quality Engineer, BD


    "Good details on key aspects including being up-to-date with MDRs, etc."

    Vincent N., Head of Innovation, Terumo Aortic


    “The course was very valuable to my knowledge and will be applying it to my position and keeping track of a good documentation.”

    Martha M., Project Management Coordinator, Ormco Corp.


    “Course addressed a variety of useful and interesting topics.  Covered all aspects of design control.  Interesting and challenging exercises.” 

    Andrew R., Scientific & Regulatory Affairs Manager, MLT Research Ltd


    “This course was extremely thorough.  Design controls are now completely understood.  The course was extremely informative.  The instructor knew the topic and passed on their knowledge.  All things were presented in a professional and excellent manner.  The course director is a wonderful teacher.” 

    Christine W., Design Drafter, EBI, LP


    “Very comprehensive coverage of topic with thorough references.  Examples were appropriate to demonstrate the use of the tools.” 

    Jerry D., Research Scientist-Engineer, Pfizer


    “The course was helpful both in validating things I learned from experience and pointing out where I made errors.”

    Ralph H., Principal Engineer/Project Engineer, Analogic Corp.


    “The course director was very knowledgeable of the design control process and answered all my questions thoroughly.”

    Angela W., Sr. Product Development Engineer, Surgical Specialties


    “Excellent course.  Small number of students was very helpful in engaging in discussion, etc.” 

    Andrew B., Senior Regional Auditor, Pfizer U. K.


    “I came into the course wondering how I could link design control concepts to QC testing of reagents in a diagnostic test that is being developed in my company.  I feel that the course material and the way in which it was taught definitely helped me understand how I can get my job done more efficiently and what is really required in order to adequately assess various risk management issues as they relate to the above-mentioned diagnostic test.” 

    Thomas V., Product Development Scientist III


    “Good overview of device design control with a great range of topics addressed, including an impressive overview of CFR 820.30 and ISO 13485:2003!” 

    Martin P., Sr. Scientist, Pfizer

FAQs

  • What materials come with the course?

    A course notebook is provided that contains the slides that are presented, publicly available reference materials from FDA and other entities, class exercises, and example documents and procedures.

  • Which ISO standards will be covered in this course?

    The course covers ISO 13485-2016, ISO 14971:2019 and its companion ISO TR 24971.

  • Are there particular types of medical devices emphasized?

    No. A wide variety of medical device types are affected by the regulation, thus a broad view is presented.  However, in the sections of case studies and specific topics, certain devices including infusion pumps, syringes, surgical instruments, SaMD, and implantables are discussed.

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.