NEW Workshop !! Successful offering this past May. Stay tuned for another session in the fall.
Software Quality and FDA: the Lean-Agile Way ---- A live workshop in Medical Software Development using Lean-Agile Methodologies offered in cooperation with MDG in Boston
----
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
New Clients
New Project has begun with Proven Process Medical Devices working on a class III medical device. New Harbor is providing Software Quality oversight and Software Risk Management for the entire project. We are again collaborating with ShoeBar Associates and working with team members from several geographic locations.
Recent client projects include custom SQA training development for a company in the consumer products market. Collaborated with other professionals to deliver test management, planning and execution in the Medical Product arena for a Class II device. A strategic planning initiative, including guidance and coaching to senior management of a major Massachusetts non-profit organization.
In 2008, we remain on a retainer basis with one of our long-term clients, providing ongoing SQA and Quality Management support for their supply base, customer satisfaction and new technology development activity.
In our spare time, we have been involved in several ventures and new opportunities with a continued emphasis in the Medical Device and Healthcare IT arena.
Courses/Workshops
Training – In collaboration with local colleges, we have developed a Professional Development Series of courses and tutorials in Software Quality and Testing for Commercial Software as well as the Medical Device Industry. Highlights of the program include:
- Teaching the Principles and Practical Methods of Software Quality Assurance within the Context of the Software Development Lifecycle
- Broad Based Approach and Best Practices from Across the Industry
- Curriculum is Aligned with Internationally Recognized Bodies of Knowledge from ASQ, SEI, IEEE and PMI
- Custom designed and delivered on site for your company if required
Stay tuned for further announcements as we roll out The New Harbor Institute in 2008!
Professional Associations
MDG Medical Software SIG, Vice Chairmanship and Co founder - Tony Raymond and co founder Brian Shoemaker begin their 3rd year leading the Medical Software Special Interest Group. As part of the Medical Development Group (MDG) this SIG was formed to pursue education and professional development in this sub-segment of the medical device and medical technology field.
The group’s focus is all aspects of software in the medical field, from embedded device software to production and quality support software, to clinical data management and healthcare applications.
Archives
2011
Medical Development Group Forms New Special Interest Group Focused on Medical Software
Waltham, MA, August 12, 2009 – Medical Development Group (MDG) announces that it has formed its second Special Interest Group to pursue education and professional development in a sub-segment of the medical device and medical technology field.
The newly constituted Medical Software Special Interest Group (MSW SIG) will focus on all aspects of software in the medical field, from embedded device software to production and quality support software, to clinical data management and healthcare applications.
For further information, click here to be redirected to the MDG website or contact either of the MSW SIG co-chairs:
Tony Raymond, New Harbor SQA, LLC
Phone: 978-965-2111; e-mail: tonyraymond@newharborsqa.com
Brian Shoemaker, ShoeBar Associates
Phone: 781-929-5927; e-mail: bshoemaker@shoebarassoc.com
Neuroprosthetic Symposium
On September 16th, 2009 a very important Neuroprosthetic Symposium will be held at the Worcester Polytechnic Institute. This symposium is sponsored by the Center for Neuroprosthetics at WPI’s Bioengineering Institute (BEI). The Center for Neuroprosthetics’s mission is to successfully perform and integrate the enabling basic science and engineering necessary to achieve implantable limb prosthetics. The goal is that for amputees, these implantable neuroprosthetics will have the functional attributes of natural limbs. To promote integrated neuroprosthetics research, this Symposium will be broad in its scope with an appeal to scientific and bioengineering issues. The Symposium will bring together academic, industry, and government research leaders to provide a forum for enhancing the integration of the applied science and engineering necessary to achieve functional implantable limb prosthetics.
For further information, click here to be redirected to the WPI website.
The Boston Section of the American Society for Quality recently presented Tony Raymond, President of New Harbor SQA with their Boston Society Award. This annual award is given to members who have Demonstrated Meritorious And Most Distinguished Achievement On Promoting The Quality Principles And In Exemplifying The Ideals Of The Quality Profession. Tony was presented the award by Harold Greenburg on behalf of the Executive Committee and Chairman Gil Andrade at the organization’s annual quality conference BOSCON 2008 this past April at Regis College in Weston MA.
The American Society for Quality (ASQ) is the world's leading authority on quality. With more than 100,000 individual and organizational members, this professional association advances learning, quality improvement, and knowledge exchange to improve business results, and to create better workplaces and communities worldwide.
Tony Raymond was recently selected to be a MassExcellence examiner for 2007-2008. MassExcellence provides Massachusetts organizations and their leadership a Baldrige-based performance assessment with a proven framework and methods that enable them to achieve measurable improvements in performance. In addition, MassExcellence recognizes superior organizations through the prestigious Massachusetts Performance Excellence Award.
