Tag

agile
Oriented for Central European Time! Registration now for our next “Being Agile and Yet Compliant” Training Course.  Our fall offering is coming up.  Conveniently scheduled to work across many timezones! COURSE DATES: February 12-15, 2024 (16 hours of training) HOURS:  1300-1700 CET each day TRAINING LOCATION: Virtual – live online COST: 4 half days for...
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By Ron Baerg and Mike Russell “You can pay me now, or you can pay me later” was the punch line of a memorable TV commercial by the FRAM® company about their oil filters around 50 years ago. The “me”: a car mechanic. Their point: paying (a little) now to replace your oil filter regularly...
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New to medical device software?  Our partners Mike Russell and Ginny Kwan Gattinger will be presenting a Regulatory Affairs Professional Society (RAPS) webinar on Wednesday, May 17, 2023 at 1:00 pm EDT to discus the unique and amplified challenges with software development for SiMD and SaMD.  They will discuss approaches for addressing the challenges and...
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Registration now for our next “Being Agile and Yet Compliant” Training Course.  Our fall offering is coming up.  Conveniently scheduled to work across many timezones! COURSE DATES: December 12-15, 2022 (16 hours of training) HOURS:  11 am until 3 pm EDT each day TRAINING LOCATION: Virtual – live online COST: 4 half days for $1,920...
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New Date! COURSE DATES: May 9 – 12, 2022 (16 hours of training) HOURS:  11 am until 3 pm EDT each day TRAINING LOCATION: Virtual – live online COST: 4 half days for $1,920 per person Registration Link:  https://events.eventzilla.net/e/2022-softwarecpr-agile-and-compliant-training-course-2138816565 Only a limited number of discounted seats are available.  For more information on the course, use...
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(March 1, 2021)— Mike Russell has joined Crisis Prevention and Recovery LLC (DBA SoftwareCPR ®) as a Partner. He is not new to the firm and industry, having assisted on many engagements in the last decade as an Affiliated Expert. He was also on the TIR working group that created the AAMI TIR45- 2012 Technical...
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Compliance and Agile In a prior blog, we discussed a common hurdle to achieving agile benefits: focusing on isolated software process changes and not considering all four organizational factors. Another common hurdle to agile success is thinking only about making agile “compliant.” You will miss the full power of agile if you do not consider...
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“Agile” remains a hot topic in general, and “compliant agile” is a goal in many medical (and other regulated) companies. However, “agile” also remains difficult and elusive for many. This article will examine one of the most common hurdles to achieving agile benefits from well-intentioned initiatives. First, let’s address agile and medical device development in...
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Does FDA accept regulatory submissions for medical devices and SaMD that have software developed using agile methods? What about IEC 62304 compliance?  Can agile and lean approaches to software development be compliant? On February 18th and 19th, 2019, we will explore those topics and more at our 2019 “Being Agile & Compliant” public training course. ...
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COURSE DATES: February 18 – 19, 2019 TRAINING LOCATION: Tampa, Florida, USA COST: 2 Full Days for $2,495.00 January Registration Discount of 10% available through Jan 19, 2019. Extended to 1/25/2019. Ask about our multi-student discount as well! Meet our newest partner, John Murray, at the course! Download registration form Only a limited number of...
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A short, short time ago, in this very own galaxy some companies were not making blockbusters, but medical devices. Whispers of quicker development times and better testing made the way past the water cooler until it became time to indulge and implement the mythical software development lifecycle. With the changes came weird language and rumors...
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Testing activities should neither end with the release of the product nor once test documentation is complete, but should continue with the reduction of any test debt. Test debt is essentially a form of technical debt. Like technical debt, test debt is incurred during a project when compromises are made in the creation of test...
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The link provided is to a YouTube video by Henrik Kniberg on Agile Methods on key concepts focused on product ownership. Youtube – Agile Methods
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The pdf at the link provided contains slides from a presentation by Brian Pate providing an overview of the soon to be released “Agile Methods for Medical Device Software Development” Technical Information Report (TIR). These slides focus on the TIR. We have posted another slide set in our library with some training slides on SoftwareCPR...
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The slides from a SoftwareCPR presentation on compliant use of Agile Methods for medical device software development is at the link provided. This was prepared and presented by Brian Pate and Mike Russell and similar slides are used in SoftwareCPR’s public courses. SCPRed_AgileForMedicalDevices-SoftwareCPRpresentation101010
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SoftwareCPR Training Courses:

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:  June 5-7, 2024
Boston, MA

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

Registration Link:

Register Now

 


 

Being Agile & Yet Compliant (Public or Private)

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

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

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: February 12-15, 2024

Virtual via Zoom

Registration Link:

Register Now

 


 

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

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