Events Calendar

As a member benefit, MassMEDIC holds an Annual Conference in May, an Annual MedTech Investors Conference in October and a series of informational programs throughout the year on a wide range of topics of interest to MassMEDIC members, including regulatory affairs, product development trends and reimbursement issues.

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  • Other Events of Interest

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  1. May
    31
    Wed

    1. Webinar: Developing and Testing User Interface Requirements
      12:00 pm – 1:00 pm

          

       

       

       

      Present

       

       

      May 31, 2017

      12:00  – 1:00  PM EDT

      Register online for this free webinar here.

       

      The focus of this webinar will be the regulatory guidelines for developing human factors-related requirements as part of the User Interface Specification. We will discuss the guidelines for developing and testing user interface requirements, including who should be involved in the process. A case study will be presented based on human factors best practices and lessons learned.
      The webinar will include:

      • Existing guidelines on user interface requirements (IEC 623662-1, FDA Guidance, HE75)
      • Best practices for writing user interface requirements
      • Who should contribute to the process
      • Helpful sources to reference
      • The relationship between risk and user interface requirements
      • Verifying user requirements
      • Testing methodologies
      • Acceptance criteria
      • A case study demonstrating development and testing of user interface requirements

      Farm Design, Inc. Presenters:

      Tara Feuerstein, Human Factors Engineer

      Kelly Gordonvaughn, Principal Human Factors Engineer and Program Manager

      After registering, you will receive a confirmation email containing information about joining the webinar.

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      +
      12:00 pm
      Webinar: Developing and Testing User Interface Requirements
  2. Jun
    8
    Thu

    1. Register
      World MedTech Regulatory Update
      8:00 am – 3:00 pm

      The same organizations that bring you the Annual FDA Update program each December – ASQ Biomedical Division/New England Discussion GroupMassMEDIC and RAPS – present World MedTech Regulatory Update. Join your medical device colleagues for a day of briefings on breaking regulatory news from the EU, South America and Asia. This day-long session will feature presentations on the European Union’s Medical Device Regulations; implementation of EN 13485; the IVD Regulations; MEDDEV 2.7.1 Rev 4, Clinical Evaluation; the MDSAP Audit Process, along with updates on device regulations in China, South America and India.

       

      AGENDA

      7:30 a.m.

      Registration / Continental Breakfast / Networking

       

      8:00 a.m.

      Welcoming Remarks

      EU – Current Status of Medical Device Regulations
      Agnieszka Jarmula, Esq., Senior Advisor, Food Safety, Health and Consumer Affairs, Delegation of the European Union to the United States

       

      8:30 a.m.

      Implementation of EN 13485 – Strategies for Success
      Mark Swanson, Director of Operations for Upper Great Lakes Region, Regulatory and Quality Solutions

       

      10:30 a.m.

      Networking Break 

       

      11:00 a.m.

      IVDR Update – Get Ready for the Ride
      Carol Ryerson, Senior Principal Advisor, RCRI

       

      11:30 a.m.

      MEDDEV 2.7.1 Rev 4, Clinical Evaluation
      Alan Eller, Vascular Product Expert, BSI

       

      12:00 p.m.

      Luncheon

       

      1:00 p.m.

      The MDSAP Audit Process: Everything you always wanted to know about MDSAP but were afraid to ask!
      Connie Hoy, EVP Regulatory Affairs and Clinical Development, Cynosure, Inc.

       

      2:00 p.m.

      Asian Update
      An overview of key regulatory changes and requirements in Japan, China, and India
      Ames Gross, Pacific Bridge Medical

       

      3:00 p.m.

      Conference Adjourns

       

      +
      8:00 am
      World MedTech Regulatory Update
  3. Jun
    20
    Tue

    1. AdvaMed & MassMEDIC co-hosting the 2017 Women’s Executive Network Conference
      8:00 am – 6:30 pm

      MassMEDIC members can register at the AdvaMed Member Rate!

       

      Join us in Cambridge, Massachusetts on June 20th for a highly interactive day that is sure to be filled with robust discussion, learning, and networking focused on improving gender diversity in the leadership and executive ranks across medtech.

       

      This unique one day event will provide you the opportunity to gain insights from industry leaders, network with senior executives from across medtech, and will help you develop strategies to help not only drive diversity within your own company but also help you further your own individual career growth and advancement.

       

      View the agenda, speakers, registration details, and more here.

      +
      8:00 am
      AdvaMed & MassMEDIC co-hosting the 2017 Women’s Executive Network Conference
  4. Aug
    2
    Wed

    1. Register
      Software Development for Medical Device Manufacturers – An intensive two-day course
      8:00 am – 12:00 am

      AN INTENSIVE 2 DAY COURSE
      August 2 and 3rd – 8:00 am to 4:00 pm 

      Developing software in compliance with FDA, EU regulations and international standards is challenging. This two-day intensive course provides practical guidance and suggestions for developing software that complies with applicable FDA and EU regulations, FDA guidance documents related to software and international standards including IEC 62304 and ISO 14971. The focus of this course is interpreting the FDA QSR regulation and guidance documents for software. Each section of the FDA Design Controls regulation (820.30) is discussed from the software perspective along with corresponding requirements from IEC 62304.

      In-depth discussion of critical topics such as Requirements, Software Verification & Validation, and Risk Management are included. In addition, techniques for validating software development tools and software used in Manufacturing and Quality Systems are also discussed. Interactive group exercises are included to facilitate discussion and learning.

      WHO SHOULD ATTEND

      Software and firmware engineers, software managers, RA/QA staff, validation engineers, and project managers. Anyone interested in learning how to develop medical device software in compliance with regulations, standards and guidance documents.

      COURSE OUTLINE

      • Introduction
        • Medical Device Definitions – FDA and EU
        • Regulatory Roadmap and FDA/EU Device Classification Schemes
        • FDA Regulations and Guidance Documents for Software
        • Standards – ISO 13485, IEC 62304, ISO 14971, EN-14971, IEC 60601, and IEC 62366-1
        • All Software is Defective
           
      • Interpreting Design Controls for Software
        • Software Development Models
        • Design and Development Planning
        • Design Inputs
          • About Requirements…
          • Requirements Exercise
        • Design Outputs
        • Design Reviews
        • Design Verification
          • Software Verification Techniques
        • Design Validation
          • Software Validation Process
          • Validation Exercise
        • Design Transfer
        • Design Changes
        • Design History File
           
      • Validation of…
        • Software Tools used to develop Medical Device Software
        • Software used in Manufacturing
        • Software used in Quality Systems
           
      • Risk Management
        • Standards and Regulations
        • Terms and Concepts
        • Risk Management Process
        • Risk Management Tools and Techniques
          • Fault Tree Exercise
        • Data Collection and Analysis
        • Documentation Requirements
           
      • Summary
         
      • Comprehensive reference materials included

       

      Speaker Bio:

      Steven R. Rakitin has over 40 years’ experience as a software engineer including 25 years of experience in the medical device industry. He has worked with over 85 medical device manufacturers worldwide, from startups to Fortune 100 corporations. He has written several papers on medical device software risk management as well as a book titled: Software Verification & Validation for Practitioners and Managers. 

       He received a BSEE from Northeastern University and an MSCS from Rensselaer Polytechnic Institute. He earned certifications from the American Society for Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He is a Senior Life member of IEEE and a member of MassMEDIC.

       As President of Software Quality Consulting Inc., he helps medical device companies comply with FDA regulations, guidance documents, and international standards in an efficient and cost-effective manner.

       

      Registration: $599 – includes all meals and background materials.

      +
      8:00 am
      Software Development for Medical Device Manufacturers – An intensive two-day course
  5. Aug
    3
    Thu

    1. Register
      Software Development for Medical Device Manufacturers – An intensive two-day course
      12:00 am – 4:00 pm

      AN INTENSIVE 2 DAY COURSE
      August 2 and 3rd – 8:00 am to 4:00 pm 

      Developing software in compliance with FDA, EU regulations and international standards is challenging. This two-day intensive course provides practical guidance and suggestions for developing software that complies with applicable FDA and EU regulations, FDA guidance documents related to software and international standards including IEC 62304 and ISO 14971. The focus of this course is interpreting the FDA QSR regulation and guidance documents for software. Each section of the FDA Design Controls regulation (820.30) is discussed from the software perspective along with corresponding requirements from IEC 62304.

      In-depth discussion of critical topics such as Requirements, Software Verification & Validation, and Risk Management are included. In addition, techniques for validating software development tools and software used in Manufacturing and Quality Systems are also discussed. Interactive group exercises are included to facilitate discussion and learning.

      WHO SHOULD ATTEND

      Software and firmware engineers, software managers, RA/QA staff, validation engineers, and project managers. Anyone interested in learning how to develop medical device software in compliance with regulations, standards and guidance documents.

      COURSE OUTLINE

      • Introduction
        • Medical Device Definitions – FDA and EU
        • Regulatory Roadmap and FDA/EU Device Classification Schemes
        • FDA Regulations and Guidance Documents for Software
        • Standards – ISO 13485, IEC 62304, ISO 14971, EN-14971, IEC 60601, and IEC 62366-1
        • All Software is Defective
           
      • Interpreting Design Controls for Software
        • Software Development Models
        • Design and Development Planning
        • Design Inputs
          • About Requirements…
          • Requirements Exercise
        • Design Outputs
        • Design Reviews
        • Design Verification
          • Software Verification Techniques
        • Design Validation
          • Software Validation Process
          • Validation Exercise
        • Design Transfer
        • Design Changes
        • Design History File
           
      • Validation of…
        • Software Tools used to develop Medical Device Software
        • Software used in Manufacturing
        • Software used in Quality Systems
           
      • Risk Management
        • Standards and Regulations
        • Terms and Concepts
        • Risk Management Process
        • Risk Management Tools and Techniques
          • Fault Tree Exercise
        • Data Collection and Analysis
        • Documentation Requirements
           
      • Summary
         
      • Comprehensive reference materials included

       

      Speaker Bio:

      Steven R. Rakitin has over 40 years’ experience as a software engineer including 25 years of experience in the medical device industry. He has worked with over 85 medical device manufacturers worldwide, from startups to Fortune 100 corporations. He has written several papers on medical device software risk management as well as a book titled: Software Verification & Validation for Practitioners and Managers. 

       He received a BSEE from Northeastern University and an MSCS from Rensselaer Polytechnic Institute. He earned certifications from the American Society for Quality (ASQ) as a Software Quality Engineer (CSQE) and Quality Auditor (CQA). He is a Senior Life member of IEEE and a member of MassMEDIC.

       As President of Software Quality Consulting Inc., he helps medical device companies comply with FDA regulations, guidance documents, and international standards in an efficient and cost-effective manner.

       

      Registration: $599 – includes all meals and background materials.

      +
      12:00 am
      Software Development for Medical Device Manufacturers – An intensive two-day course

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