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. 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
  2. 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
  3. Aug
    7
    Mon

    1. 7th Annual Summer Social and Networking Event (Including Lightning Pitches!…
      7:30 am – 10:30 am

       

       

      New England Healthcare Executive Network

      August 7, 2017, 7:30AM to 10:00AM

      7TH ANNUAL SUMMER SOCIAL AND NETWORKING EVENT INCLUDING LIGHTNING PITCHES!

      Location:
      FOLEY HOAG LLP, Seaport West, 155 Seaport Boulevard, Boston
      For Driving and Parking Information, Click Here.


      Program Description

      Our event of the year that you don’t want to miss! We are pleased to announce the 7th Annual Summer Social Networking Event Including Lightning Pitches and Keynote Speaker David O’Dowd from Draper Labs to be held on August 7. This program features a number of snapshot presentations (i.e. lightning pitches) from local pre-venture and early stage Life Science companies. Each pitching company will have 1 minute to impress us with their value proposition and there will also be plenty of opportunity to network with the companies and fellow members. This is one of our most well-attended events of the year, with health innovation professionals from all backgrounds coming to see what’s new and exciting in the local biotech, medtech, pharma and health IT economy.

      Please feel free to preregister now if you plan to attend. If you want to participate in the lightning pitches please fill out the brief application form here by July 21. We typically let you know within a few days if you have been selected to participate so you can begin work on your slide. Company’s pitches are presented in the order in which they registered for the event.


      Keynote Speaker:

      David O’Dowd, Associate Director in the Biomedical Solutions group, Draper Laboratory

      David’s responsibilities are to identify technologies developed at Draper which have potential to address significant clinical unmet needs.

      Presentation: Improving Drug Discovery and Manufacturing through Microfluidics

      Currently, only 1 in 10 drugs starting clinical trials successfully makes it to market. Once approved, some therapeutics, such a cell therapies, face challenges in efficiently manufacturing a consistent product. In this talk, David will share some of the ways Draper has leveraged its expertise in creating biologically friendly and scalable microfluidic structures to increase the odds of success in drug discovery and bring reliable, cost effective cell therapies to the patient bedside.

      About Draper Laboratory

      Draper is a non-profit research and development company focused on the design, development and deployment of advanced technological solutions for the world’s most challenging problems. Draper’s Biomedical Solutions encompass organ-on-chip systems, cell therapy bioprocessing, rapid diagnostics and neurotechnology. Draper works closely with commercial partners to transition our technology into their hands, ensuring that our solutions provide enduring value.

      Pitching Companies will be Confirmed in July

      Speaker Biography

      David O’Dowd, Associate Director in the Biomedical Solutions group, Draper Laboratory

      David O’Dowd is an Associate Director in the Biomedical Solutions group at Draper Laboratory where he has focused on identifying technologies developed at Draper which have potential to address significant clinical unmet need with a strong business case. Prior to joining Draper, Mr. O’Dowd was Director of Life Sciences at Forge Partners, a boutique early stage investment company from 2007-2008 and led the company’s life science investment identification and evaluation. From 2002 – 2007, he was Managing Director of DGO Consulting, providing strategic consulting services to early stage life science companies. From 2001 to 2002 he was Vice President of Business Development and Strategy at PrivaSource, Inc, which was focused on healthcare data aggregation and de-identification. From 1997 to 2001 he was Director of Development and Director of Marketing at Genomics Collaborative, a genomics start-up that built a repository of 100,000 DNA and tissue samples with detailed medical information from people around the world with common diseases. From 1992 until 1997, he was Manager at Health Advances, a healthcare-focused strategy consulting firm. Mr. O’Dowd holds a B.S. in Chemical Engineering from the University of Rochester and an S.M. in Technology and Policy from MIT.

      For More Information Click Here

      +
      7:30 am
      7th Annual Summer Social and Networking Event (Including Lightning Pitches!…

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