23

Feb

2016

62304 and Medical Device Software Stds Training

0

How does one know what standards are helpful when creating or updating your software development process?

Can compliance with standards benefit a medical device or HealthIT company with regulatory approval and/or FDA inspections?

These questions and more will be answered at the upcoming 62304 training and emerging standards impacting Medical Device software and Health IT training course sponsored by SoftwareCPR. Stay one step ahead by learning about the amendment 1 changes to 62304, the upcoming 2nd edition of 62304, and how to frame your software development process around 62304. The course will even address challenges and recommendations for making your agile process 62304 compliant! But the course is not limited to 62304 training – learn about the Health software standard, 82304, integrating 62366-1 into your SDLC, and the most efficient and appropriate software risk management methodologies. Learn more about our 62304 training course!

Don’t wait for compliance issues – act now and make sure your company is not caught off-guard and lacking appropriate training. Send us your questions below:

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

Americas: 11-13 February 2025
EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
Southern Central Northeastern Pacific: 24-26 February 2025

Register using form at this link: Agile Course Post Promo

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering: TBD

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

Email training@softwarecpr.com to request a special pre-registration discount. Limited number of pre-registration coupons.

Registration Link:

TBD

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering: TBD