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Medical Device Software: An Incremental Approach to Risk and Quality Management 2017

Start Date:
Thursday, 2 November, 2017
End Date:
Friday, 3 November, 2017 6:00pm
Immunology, Pain Management, Endocrinology, Infectious Disease, Rheumatology, Internal Medicine, Radiology, Emergency Medicine

Course "Medical Device Software: An Incremental Approach to Risk and Quality Management" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Engineers are dedicated to making things work, so a focus on how they might fail and harm someone can seem alien.Managing risk, however, is essential for all medical products- medical devices, including those involving software, have produced some painful examples of poor risk management with serious consequences.

Experience has shown that there is a better way, that it is possible to manage risk in a changing business and technical world.Regulatory bodies are placing increased emphasis on risk management, and technology shifts are introducing new sources of risk. Newer Lean-Agile methods are recognized by the FDA as a good way to accomplish risk management.Techniques for risk management are well established, but require specific interpretation when applied to software.

In this session, we will show a way of knitting risk management into the development process, so that it is integral to product development, not a ten ton caboose dragging the train back down the mountain. Why you should attend: Perhaps your engineering team is beginning its transition to an Agile approach - or perhaps you have a seasoned Agile team and you're just beginning work on FDA-regulated products. You know that risk management is required, but it's not at all clear how you should address it as you go through your backlog grooming, iterations, and end-user demonstrations.

The process in ISO 14971 seems "linear" and unsuited to a highly iterative, dynamic lifecycle. How can you fit it into your approach? Areas Covered in the Session: Software has introduced (or been blamed for) some serious safety hazardsAll medical device standards intersect on the topic of risk managementRisk analysis starts with the intended use statementRisk information is available from multipl sources - use them!Note that safety is an emergent propertyChanges are often the biggest sources of riskDon't ignore the human factors side; understanding your users is crucial to safetyApplying engineering risk methods to software requires us to translate some conceptsThough standards draw a roadmap for risk management, WE must figure out the routeRisks often arise when we add new features - so incremental risk management is the most effectiveForget the notion that "software can't hurt anyone"Never conduct risk analysis by using a checklist from 14971Exploding technology brings numerous chances for risk to multiply Who will benefit: Project managersRegulatory specialistsQuality assurance specialistsDocumentation specialistsTest managersSoftware team leaders and lead developers Agenda: Day 1 Schedule Lecture 1:Software brings great capability to medical devices, but also creates hazardsLecture 2:Consider how the key standards lay out the roadmap for managing riskLecture 3:Understand the key concepts - hazard, risk, and harmLecture 4:Walk through ISO 14971 in detail - and consider IEC 80002-1 for specific software concerns Day 2 Schedule Lecture 1:Fault tree analysis and FMEA complement each other for risk analysisLecture 2:Risk analysis for software is different from hardware - and needs a place in the lifecycleLecture 3:Story mapping helps bring risk management directly into developmentLecture 4:An incremental approach manages both risk and quality SpeakerBrian Shoemaker Brian Shoemaker consults for healthcare products companies on computer system validation, software quality assurance, and electronic records and signatures.

He has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. He has had clients in clinical diagnostics, medical device engineering, medical imaging, medical-device fabrics manufacturing, contract lyophilization, clinical trial software, dental prosthetics, and bone-repair implants.

He has worked with companies in Germany and Switzerland as well as the U.S.Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification. Location: Baltimore, MDDate: November 2nd & 3rd, 2017 and Time: 9:00 AM to 6:00 PMVenue: WILL BE ANNOUNCED SOON Baltimore, MD Price: Price: $1,295.00 (Seminar Fee for One Delegate)Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register now and save $200. (Early Bird)Until September 20, Early Bird Price: $1,295.00 From September 21 to October 31, Regular Price: $1,495.00Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.

Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts.

Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri",sans-serif;mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
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