Educational Opportunities through MDG

MDG Special Course

Software Quality and FDA: the Lean-Agile Way

A live workshop in Medical Software Development using Lean-Agile Methodologies

Date: Tuesday, October 4, 2011
Agenda: 8:30 continental breakfast, 9:00 - 5:00 course, 12:00 - 1:00 Lunch
Location: 67 South Bedford Street, Suite 400 West, Burlington, MA 01803

Course Description

We who develop software for medical applications - medical device software and more - have a safety responsibility to patients and caregivers who will use our product, but also have a responsibility to our managers and our investors to get a usable product out the door on time and within budget. And of course we can't forget that we need to fulfill regulatory requirements!

Many companies struggle with meeting all these expectations; software-related product recalls and failed companies are the legacy of traditional, sequential methods. In this one-day course, we present the basics of software quality for FDA compliance, then show how lean/agile development, properly applied, provides a solution to both high quality and high productivity.

The morning session sets out an overview: where the FDA's concerns lie, what can be changed about traditional development while retaining good practices, and how development teams can be both fast and cost-effective. The afternoon session then delves in depth into each of the key areas of concern: standards and guidance, role of a quality management system, risk management as applied to software, agile project flow, agile planning and team autonomy, and approaches to documentation when using an agile approach.

Join Tony Raymond, Brian Shoemaker, and Nancy Van Schooenderwoert as they present fundamentals of software quality for FDA compliance - with lean and agile principles to resolve quality/safety vs. cost/time.

Who should attend

Product development personnel working on medical device software, including:

  • Managers
  • Team Leaders and technical leads
  • Software developers
  • Requirements analysts
  • Quality assurance personnel

What you will learn

  • Background of the FDA regulations
  • Which FDA and international standards relate to device software - and what they really say
  • What SOPs are needed in a good software quality system
  • How to apply hazard analysis / risk management to medical device software
  • How Agile development improves speed and quality without losing FDA compliance

Registration is limited to 30 students, so be sure to register early!

Click here for a downloadable course description with directions to the course location.

Click here to register.

Registration Fee
(Includes course materials, lunch, and snacks)

  MDG Member Nonmember
Regular (through midnight September 23) $575 $635
Late (September 24 and after) $655 $715

Presented by Industry Experts

Tony Raymond Brian Shoemaker Nancy Van Schooenderwoert
New Harbor SQA ShoeBar Associates Lean-Agile Partners

Directions to course location: Click here for a map to the location; the aerial view shows the building.

From rt 128, take exit for route 3A north. Turn left onto Burlington Mall Road, then left at the stop light onto South Bedford Street. At the blue sign for 67 South Bedford, turn right and go approximately 200 yards. Take the driveway on the left. Enter at the East lobby.

MDG Educational Seminar

Medical Device Regulatory Affiars for Non-Regulatory Professionals:
What do non-regulatory professionals need to know?

Presented by
Michael Drues, Ph.D.

November 1 and 8, 2011, 5:30 PM - 9:00 PM
Padanarum Room, Reservoir Place
1601 Trapelo Road, Waltham MA

Dr. Michael Drues

Seminar Overview and Objectives:

Geared for both experienced medical device professionals as well as those new to the industry, this seminar is designed specifically for non-regulatory professionals who need a better understanding of the regulatory requirements necessary to bring new medical devices to the market. This unique seminar demonstrates important regulatory requirements and concepts through actual product case studies discussions emphasizing not simply following regulations but asking do the regulations make sense and what to do when they don’t!

Major medical device approval pathways are presented with a discussion of the advantages and challenges of each. Preclinical and clinical trial phases will be discussed highlighting how issues relate back to product design and development. Important topics such as pediatric devices, off-label use and medical device direct-to-patient advertising will also be discussed. Differences between medical devices, drugs and biologics will be discussed with emphasis on the emerging area of combination products. Some differences between domestic vs. international approvals will be touched upon. Multiple examples of medical devices and procedural videos are presented in an interactive format with a discussion of what they do well and where improvements can be made.

Upon completing the seminar, each attendee will be able to:

  • Understand the major regulatory requirements that apply to medical devices
  • Learn to work more effectively with regulatory personnel and the FDA
  • Be able to anticipate questions from FDA reviewers
  • Learn to design a regulatory strategy to minimize product approval delays
  • Appreciate the goals and challenges of medical device clinical trials
  • Understand the similarities and differences between medical devices, drugs and biologics
  • Recognize the advantages and challenges of combination products
  • Identify opportunities for future growth

Who Should Attend?

This seminar is designed especially for non-regulatory professionals involved in the design, development, and manufacture of medical devices. Those working in research and development, manufacturing, quality, business development, sales and marketing, legal, business and accounting, field service and related areas will all benefit from this seminar.

Course Fee (Includes a light dinner)
MDG Member $249 + $50 for course manual
Nonmember $349 + $50 for course manual


About the Instructor

Michael Drues, Ph.D., President of Vascular Sciences in Grafton, Massachusetts.

Vascular Sciences offers a full range of consulting services to medical device, pharmaceutical and biotechnology companies including: prototype design, product development, testing and evaluation, animal and clinical trials, business development, strategic planning, technology assessment and regulatory affairs. Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA).

Dr. Drues is an Adjunct Professor of Medicine & Biotechnology at Northeastern University (Boston), Steven’s Institute of Technology (Hoboken), Boston College (Boston), University of Wisconsin (Madison), Drexel Medical School (Philadelphia), Regis College (Boston) and University of California (Irvine). He regularly teaches both undergraduate and graduate courses in pathophysiology, biotechnology, regulatory affairs and clinical trials. Dr. Drues conducts seminars and shortcourses for medical device, pharmaceutical and biotechnology companies, the European Patent Office and the FDA. Current offerings include: Designing Cardiovascular Devices, Designing Gastrointestinal & Urinary Devices, Designing Better Medical Devices: Begin with the body in Mind™, Minimally Invasive Technologies, Combination Products and Convergence, Overview of Biotechnology, Emerging Trends in the Medical Device Industry™, Big Picture Issues in Clinical Trials™, and Regulatory Affairs for Non-Regulatory Professionals.

For more information, contact Dr. Drues (

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