Listed below are conferences and public courses related to FDA software regulation and validation that have come to our attention. Inclusion on this list does not imply any evaluation, endorsement, or recommendation by SoftwareCPR. Events at which SoftwareCPR® partners are speaking or instructing are indicated with an * asterisk.
Scroll down the list which is in chronological order.
Click FDA CDRH Workshops for FDA's device center list.
|9/24/2018||The MedTech Conference, Sep 24-26, 2018|
|Philadelphia, PA Featuressenoior level politicians and executives, a wide array of educational programming. For more information click the link provided.|
|10/1/2018||RAPS Regulatory Convergence, Oct 1-4, 2018|
|Vancouver, BC Canada . Focused on global regulatory affairs and harmonization. For more information click the link provided.|
|11/6/2018||High Integrity Software Conference, Nov 6, 2018|
|Bristol, UK. Now in its fifth year, the mission of the High Integrity Software conference is to share challenges, best practice and experience between software engineering practitioners. The conference features talks from industrial and academic specialists which disseminate experience and knowledge of important techniques and methods that are applicable across industry sectors. For more information click the link provided.|
|11/8/2018||FDA CDRH Special 510(k) Program Pilot Webinar|
|For more information on this webinar click the link provided.|
|11/12/2018||Medica, Nov 12-15, 2018|
Largest medical trade fair in the world. Each year, leading individuals from the fields of business, research, and politics attend this top-class event.. For more information click the link provided.
|11/15/2018||FDA CDRH Paitent Advisory Committee Public Meeting|
|For more information on this meeting click the link provided.|
|2/18/2019||Being Agile & Compliant - SCPR Public Course*|
|Being Agile & Compliant Software CPR Public Training Course|
COURSE DATES: February 18 - 19, 2019
TRAINING LOCATION: Tampa, Florida, USA
COST: 2 Full Days for $2,495.00
Early Bird Registration Discount of $500 available through Nov 30th, 2018.
Only a limited number of early bird registration seats are available - Email now!
Send email to: email@example.com
Our course is framed around IEC 62304 and how the standard can be used to ensure agile methods and approaches to software development.
Discuss the proper activities and deliverables for safe and effective software.
Uses concepts from AAMI TIR45 as well to help communicate how agile methods can, when used properly, improve software quality.
Reference US regulations and FDA guidance to address potential gaps that can occur with some agile approaches.
Understand how backlog management, development iterations, and release cycles can easily align with the intent and expectations of regulators and auditors.
Discussion on tools and the very important role they MUST play in the effective use of agile methods for medical device and digital health software.
Integrated exercises designed to apply learning!
This 2 day course will be taught by Brian Pate and Ron Baerg of SoftwareCPR®.
Brian was a member of the AAMI working groups that developed TIR32 Medical Device Software Risk Management and TIR45 Effective Application of Agile Practices in the Development of Medical Device Software. Brian currently is the lead faculty for the AAMI Regulatory Requirements for Software Validation course and is co-faculty for the AAMI Agile course. Ron has over 23 years in developing medical device software for many levels of safety risk. Full credentials on our website: https://www.softwarecpr.com
Who Should Attend?
Quality Assurance and Regulatory Affairs professionals. This course will provide a clear understanding of requirements versus areas of flexibility and provide checklists and questions to use for gap analysis, auditing, and vendor and OEM qualification and management.
Product Owners, Scrum Masters/Coaches, software development managers/engineers, risk management, and test engineers. This course provides examples, checklists, and partial templates as well as improving articulation and defense of your approaches to regulatory bodies, internal quality assurance, and regulatory affairs departments.
Center for Advanced Medical Learning and Simulation (CAMLS). As one of the world's largest, free-standing centers fully dedicated to training healthcare professionals, the 90,000-square-foot, three-story facility provides a state-of-the-art, clinical environment with 60,000 square feet dedicated to surgical skills labs, operating suites, a virtual hospital and simulation center, and more than 25,000 square feet of dedicated education and conference space. Conveniently located in the heart of downtown Tampa, FL, it is open 7 days a week to accommodate the numerous demands that challenge today's healthcare providers and researchers as well as its numerous international clients.
Several hotels are within 1 or 2 city blocks of CAMLS. No rental car is needed as many restaurants, shopping and entertainment are easily accessible in the Tampa Riverwalk and Channelside district.
For more information email: firstname.lastname@example.org