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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  1. Jun
    6
    Mon

    1. Robotica 2016-June 6-9, 2016 (all-day)
      Jun 6

       

      June 6-9, 2016

      Devens, Massachusetts

       

      For More Information Click Here: Robotica2016

      +
      Robotica 2016-June 6-9, 2016 (all-day)
  2. Jun
    15
    Wed

    1. Register
      Women in MedTech Forum – Defining Yourself and Your Career: Negotiating With Strength
      8:30 am – 10:30 am

      women in medtech logo_small

      What is strength in a negotiation, and is it something you can develop by yourself?  What are your options, and how do you ask the right questions to figure that out?  What is a “win”?

      Much has been written and discussed about gender differences in negotiating styles, particularly in the context of employment, promotions, and salaries.  This Women in MedTech program explores career-based negotiations from all perspectives: job seekers, promotion candidates, and those who are considering such applications.  Join our panel of coaches and industry professionals as they discuss these negotiation dynamics in general, and lead a series of break-out sessions to dissect specific scenarios, strategies, and skills in more detail.

       

      Agenda

      8:30am

      Coffee & Registration

      9:00am – 10:30am

      Program and Networking

      +
      8:30 am
      Women in MedTech Forum – Defining Yourself and Your Career: Negotiating With Strength
  3. Jun
    24
    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
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      8:00 am
      Project Portfolio Management: Medical Device Industry Perspectives
  4. 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

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