@softwarecpr

FDA and ISO/IEC Regulatory Consulting. Onward to higher software quality!
Crisis Prevention and Recovery, LLC

[Wes Huff @WesleyLHuff]

This Easter, I invite you to look at Jesus, consider what he said and did, and ask for yourself what I believe is the most important question you will ever answer: Did he really leave behind an empty tomb? And if he did, what does that mean for you?

This video was made possible and in collaboration with my friends at @ChildlikeMedia.

[@softwarecpr @softwarecpr]

https://t.co/nIxtexCbjU

[@softwarecpr @softwarecpr]

"I am the Lord. Besides Me, there is no Savior.
From today on I am He alone, and none can rescue from My power. I act, and who can reverse it?” #sovereign #isaiah43

[@softwarecpr @softwarecpr]

Do you see a man skillful in his work?
He will stand before kings;
he will not stand before obscure men. Proverbs 22:29
- Let us sharpen our design skills and quality assurance methods. 💡

[@softwarecpr @softwarecpr]

@PaulGoldEagle @grok what exactly are the side effects?

[@softwarecpr @softwarecpr]

https://t.co/ZpjfOGJfLk

[@softwarecpr @softwarecpr]

Just the time I feel that I've been caught in the mire of self,
Just the time I feel my mind's been bought by worldly wealth.
That's when the breeze begins to blow, I know the Spirit's call,
And all my worldly wanderings just melt into His love.

When my daily deeds ordinarily lose life and song,
My heart begins to bleed, sensitivity to Him is gone.
I've run the race but set my own pace and face a shattered soul,
Now, the gentle arms of Jesus warm my hunger to be whole.

Oh, I want to know You more
Deep within my soul, I want to know You
Oh, I want to know You
To feel Your heart and know Your mind
Looking in Your eyes stirs up within me
Cries that say, "I want to know You"

Oh, I want to know You
And I would give my final breath
To know You in Your death and resurrection
Oh, I want to know You more

-Steve Green

[@softwarecpr @softwarecpr]

Let no one deceive himself. If anyone among you thinks that he is wise in this age, let him become a fool that he may become wise. For the wisdom of this world is folly with God.
For it is written, “He catches the wise in their craftiness,” and again, “The Lord knows the thoughts of the wise, that they are futile.”
— 1 Corinthians 3:18-20

[Governor Tate Reeves @tatereeves]

Why invest in Mississippi?

@elonmusk says it best:

“Insane execution speed”

We can get you from spending money to making money faster than any state in America.

And that’s our competitive advantage!

[Aaron Siri @AaronSiriSG]

Here are a few quotes from HHS’s report changing the CDC schedule you don’t see every day in a government document!

“Among the fundamental principles of public health are respect for personal autonomy and self-determination, and informed consent is a cornerstone of medical care.”

“As with all medical procedures, vaccine decisions should never involve coercion but instead should always be the result of informed consent and with the final decision resting with the patient/parents. Coercion renders informed consent invalid and undermines this basic right.”

“It is generally considered contrary to basic medical ethics to coerce or require a medical intervention, and informed consent is a cornerstone of medical care in the U.S. and abroad.”

“Scientifically valid rates of adverse events are rarely available to determine the relationship, if any, between our country’s immunization schedule and the increasing prevalence of chronic diseases in American children.”

“A fundamental principle of public health is trust. For the public to trust public health agencies, those agencies must trust the public, which includes providing accurate information and being honest when the scientific knowledge is incomplete.”

“Given the growing distrust that the American people have in the current childhood vaccine schedule, there is a need for more and better science, including gold standard placebo-controlled randomized trials.”

“Vaccines may cause adverse reactions that occur or are diagnosed months or years after vaccination.”

“…the mere existence of a vaccine does not automatically make it appropriate for every child, nor does it necessarily justify routine vaccination”

“A successful childhood immunization program must be built on solid scientific evidence. This means … [a]pprovals of new vaccines designed for mass uptake should be based on double-blind placebo-controlled randomized trials. This has seldom been the case.”

https://t.co/1wfETHinOU

[@softwarecpr @softwarecpr]

Great internal discussion today on "Architecting for Testability." Many will see that phrase and immediately react with yes! If you know, you know! The best system architects and software architects are considering test interfaces as they design.
Have you ever encountered a system where it was difficult to do the tests you really wanted to do, and were stuck with system level, black box tests knowing that there were many states and conditions that would go untested?
#highquality #riskmanagement #safety #fewerrecalls #softwarecpr

[@softwarecpr @softwarecpr]

SoftwareCPR is planning a series of training courses in #KualaLumpur, #Malaysia (for Malaysian citizens). Our instructors understand regulatory agency expectations, including US #FDA and EU,  and can train your staff accordingly and coach them on how best to articulate and defend your approaches in FDA and international standards terminologies. Our instructors have been in involved in software standards development including #iec62304, #iso13485, #Cybersecurity, #iec60601_1 PEMS, #ul1998 & #ul5500, and AAMI #tir45 and can train your staff in pragmatic and efficient methods of conformance to standards.

Our training can be tailored to your needs, your products, your regulatory perspective, and your business objectives. Our training includes FDA enforcement examples, key FDA guidance, electronic, checklists, and other educational aides. We provide real-life examples and help apply the standards in practical ways.

For information and to learn more, see our website: https://t.co/li8SDZAOZ8

[@softwarecpr @softwarecpr]

Our ISO 13485 Internal Audit Training Course focuses on both the requirements of ISO 13485:2016 and the audit process and methods(ISO 19011) to ensure the manufacturer or supplier is compliant with the requirements of the standard. Our approach is to educate on the intent and purpose of the standard so that the participants are able to make informed decisions in the future. Our training is helpful for regulatory, quality, production, and engineering roles, both management and contributors.
The current standard format course covers the topics listed below:
•Quality terminology
•Management responsibility
•Resource management
•Product realization and relationship to design controls, usability, cybersecurity, and software lifecycles
•Purchasing
•Production and service provision
•Control of monitoring and measuring devices
•Measurement, analysis, and improvement
•Control of non-conforming product
•Analysis of data and improvement
•Principles of auditing
•Managing an audit program
•Preparing for audit activities
•Conducting audit activities
•Audit reporting clause
•Completing the audit
•Audit follow-up
•Selection and training of auditors
•Practical, real-world examples and discussion
•Workshops and exercises integrated throughout teaching modules
Full credentials on our website:  https://t.co/AsK5Pk1XYg
This course can be provided live, onsite or remotely (requires camera on for entire course).
COST: 3 Full Days (9:00 am to 4:30 pm) for $21,000 for up to 21 students.  Extra cost per student over 21.
Course tailoring available for a fee.
To schedule the course or have a discussion, please email us at:  [email protected]

[@softwarecpr @softwarecpr]

The international standard, ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes, provides the framework of the set of interrelated processes that work to ensure product quality.  This international standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be considered as a process. Often the output from one process directly forms the input to the next process. Like well designed software, a well designed quality management system is:
•properly decoupled (each process/system has its role and function within the overall QMS)
•clear and fully defined inputs to each process/system
•data scope is appropriate and outputs from each process/system are measurable and actionable
•risk to product quality is analyzed such that each process/system has specific controls to mitigate risks
Perhaps your QMS started out that way, but many years of quick-fix CAPA has bloated the systems and created inefficiencies. Or off-the-shelf templates were used that do not fit your products, your people, or your specific processes. Or both.
As you prepare for the US regulatory switchover to #QMSR, now is a great time to level up to ISO 13485 Quality Management Systems.  For example, do you feel that your company is using the internal audit process to ensure compliance with #iso13485 and ensure metrics based improvements are occurring? Are you seeing the continuing improvement and field quality that you would expect when the quality management system is working well?
We can help in a variety of ways. First, we can provide training to your team to become better internal auditors. Second, we can assist with the internal audit to give a 3rd party view. Third, we can do deep dives to identify more than non-compliance … we can identify process bottlenecks, inefficiencies, and waste (bloat) with our combination audit and assessment.
Contact us today if you would like to discuss. By email: [email protected]
By phone: [phone]

[@softwarecpr @softwarecpr]

We understand the tension. You get it … we all want to be process focused. Create and maintain a good process, and good outputs will come forth. But you may be the one that faces the auditor or faces the inspector. They ask for evidence that the process was performed. You think, “life would be much easier if I just had a document or record to show them.” So when deadlines approach or milestones are coming up, we can gravitate toward a document and/or record approach to our quality management processes.
Often non-value added documents and/or records can begin to accumulate. The team recognizes it. The very evidence meant to show “good” process is now robbing scarce time from the team. No one wants to remove the evidence requirement from the process – even though all agree it is non-value added. The overall process lacks sufficient metrics so that you could actually measure whether the activity, when removed, has any impact on product quality.
Sound familiar?
Let’s right-size and benchmark our #qms against #iso13485 and related process standards. Let’s use product quality risk to identify the controls (and metrics!) we need to create both effective and efficient processes. You’ve got this. If you would like a jump start or help, let’s talk.
Need training?  Consider our live, 3-day ISO 13485 Internal Audit(or) Training Course. Email [email protected] for price quotes and tailoring opportunities.

[@softwarecpr @softwarecpr]

Timely article :)
It is never as simple as you think.
https://t.co/b4RwBJzlND

[@softwarecpr @softwarecpr]

@softwarecpr Partner and General Manager, Brian Pate, will be teaching our very popular 3-day #iec62304 #software training course June 24-26, 2025 at one of our clients in #boston. The course is freshly updated with detailed explanation of intent of the standard with richly explained examples and trade-offs. Also fresh #fda insight from recent submissions.
https://t.co/mzJPmTUhNe

[@softwarecpr @softwarecpr]

#iec62304 The software system is software safety class A if the software system:
- cannot contribute to a hazardous situation; or
- can contribute to a hazardous situation which results in acceptable risk after consideration of risk control measures external to that software system.
https://t.co/mzJPmTUhNe

[@softwarecpr @softwarecpr]

By developing #medicaldevice #software in phases or stages as part of a lifecycle #sdlc, you give yourself the opportunity to “measure.”
Why is that important?
What do we measure?
It is important because it allows you to prove (or argue) that you have accomplished what you planned to do for that particular phase or stage. "We planned to add this functionality and we now argue that we successfully added the functionality because of the following #softwareverification evidence." The software verification is your "measurement" of the software correctness. Essentially you will make an argument for the quality of the software at the phase or stage endpoint.
The manufacturer is free to define the phases or stages that best fit the organization, the products, the type of software, the frequency of release, etc. The manufacturer also defines what will be measured to demonstrate quality. While evidence of these measurement activities will be examined by the regulator, we encourage our clients to develop and embrace a "quality mindset," and not simply a "#compliance mindset." That is, do what you believe produces the highest quality software and have documentation to support that. Avoid wasteful activities and documentation simply because you believe a regulator requires that.