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.

Categories ▾
  • MassMEDIC Events
  • Other Events of Interest

+ Expand All − Collapse All Today Agenda

  1. Jun
    29
    Wed

    1. Webinar-Preparing a Robust 510(k) Submission
      12:00 pm – 1:00 pm

       

       

       

      massmediclogoUL_Enterprise_red_rgb

      Present

      Preparing a Robust 510(k) Submission

      Join us for a free webinar

       

      Register now!

       

      As technology jumps forward and FDA works to keep abreast of the rapidly changing landscape, preparing a robust 510(k) is more important than ever. Time to market is critical, and any delays with FDA only operates to extend that time. In this webinar, we will discuss ways to ensure that the 510(k) that is submitted will have the best chance for the shorter review times that can be achieved by meeting FDA’s expectations.

      Presenter: Linda M. Chatwin, Esq., RAC
      Manager Medical Regulatory Advisory Services
      North America, UL

      Ms. Chatwin has been involved with regulated medical products for over 30 years. She understands the global regulatory maze required to bring products to market, through years of watching regulations evolve and change. She holds a Regulatory Affairs Certification and is an attorney in the U.S. She has obtained product approvals for a wide range of products, and remains involved in changing requirements for medical devices worldwide. She has navigated many FDA inspections, and has negotiated favorable outcomes with FDA. Currently, she assists clients with regulatory issues and challenges, including implementation of UDI processes, performing mock audits, in-depth training on regulatory requirements and consulting on quality system development and improvement.

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

       

      View System Requirements

      +
      12:00 pm
      Webinar-Preparing a Robust 510(k) Submission
  2. Jul
    13
    Wed

    1. Webinar – Technology Readiness: Are you ready to start Formal Product Development?
      12:00 pm – 1:00 pm

             

       massmediclogo

      sunrise_logo_blueSTANDARD

       

      Join us for a free webinar on July 13, 2016 at 12:00 PM EDT.

      Webinar – Technology Readiness: Are you ready to start Formal Product Development? 

       

       Register now!

      https://attendee.gotowebinar.com/register/3756637982292628993

       

      New product development efforts are one of the most significant investments made by medical device manufactures.

      If formal development is initiated before the technology is well understood, time and money are wasted making design changes, again and again, to solve fundamental technology performance problems. Holding off on starting formal development until the technology is fully mature has the risk that competitors will beat you to the market, early revenue will be lost, or momentum for the project will be lost.

      A technology readiness review provides an objective assessment of technical risks that may delay, or prohibit, market introduction. To determine whether a potential product has adequate technical maturity to effectively launch formal product development, the following methods should be considered:

      Determining the stage of technology development

      Understanding implications of multiple technology risks as appropriate

      Modeling and analysis to show that fundamentals of the core technology have been thought through and are capable of meeting the product requirements 

      Demonstrating the device can provide adequate performance over the expected range of conditions 

      Determining that the technology can scale to volume manufacturing and distribution 

       

      This webinar outlines methods for objective assessment of technology readiness for new product concepts, critical when moving from early development toward commercialization.

      Presenter:
      Adam Jacobs
      Chief Technology Officer, Sunrise Labs
      adam jacobs

       

       

       

       

       

       

       

      Adam is a senior level technology leader with proven success in R&D, medical device development, and product innovation. Prior to joining Sunrise, he was Executive Director of Engineering at KMC Systems and Vice President R&D for Datascope, Melasciences and JADS Technologies. Adam has brought three startup companies to successful liquidity events. He has developed many novel technologies from conception through product throughout his career.

       

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

       

      View System Requirements

      +
      12:00 pm
      Webinar – Technology Readiness: Are you ready to start Formal Product Development?
  3. Aug
    2
    Tue

    1. Register
      Software Development for Medical Device Manufacturers – An intensive two-day course
      8:00 am – 4:00 pm

       

      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, guidance documents and international standards such as IEC 62304 and ISO 14971. The focus of this course is interpreting Design Controls for software. Each section of the Design Controls regulation (820.30) is discussed from the software perspective. Corresponding requirements from IEC 62304 are woven into the flow.

      In-depth discussion of critical topics such as Requirements, Software Verification & Validation, Risk Management and Fault Tree Analysis 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 and software quality manager. He helped write the first IEEE Software Engineering Standard (IEEE-STD-730 Standard for Software Quality Assurance Plans) as well as the current revision IEEE 730-2014. He is also a member of the working group writing IEEE Standard 1012 (System Verification & Validation). He has written several papers on medical 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 Life Senior member of IEEE and a member of MassMEDIC.

      He is on the Editorial Review Board for the ASQ Journal Software Quality Professional.

      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
  4. Sep
    23
    Fri

    1. Register
      Project Portfolio Management: Medical Device Industry Perspectives
      8:00 am – 10:30 am

      Remaining relevant in a competitive market requires life cycle management of existing products and developing new innovative products at any given time.  Although the level of uncertainty and risks differ significantly, both types of projects compete for the same resource pool (budget and skills).  How can you ensure your project portfolio prioritization attends to these diverse needs, maximizes resource utilization, and is aligned with the strategic goals of the organization?  A change in the standard operating model to more effectively deal with the requirements of innovation and life cycle management projects may need to be considered.

      Is your organization prepared to field high functioning teams that can deliver on your strategic initiative?  Establishing a Project Portfolio Management (PPM) capability is a significant undertaking for any organization.  Join us for a round table discussion with industry experts familiar with the benefits and challenges associated with building and sustaining strong Portfolio, Program and Project Management practices within their organizations.

       

      Agenda

      7:30am

      Registration/Continental Breakfast/Networking

      8:00am

      Welcome and Introduction

      Topic Overview Presentation

      Panel Discussion and Audience Q&A

      Moderator: Milind Nagale, Director, Regional Operations, Integrated Project Management Company

      Panelists:

      Susan Moreira, Vice President, Research & Development, Beaver-Visitec International

      Michael Pereira, Executive Vice President, Technology & Operations, Ximedica

      Kristin Watson, Director, Project Management Office, Medtronic

      10:30am

      Program Concludes
      +
      8:00 am
      Project Portfolio Management: Medical Device Industry Perspectives

✔ Subscribe in Google Calendar