Tag

softwarevalidation
Most medical device manufacturers use many, many software programs, systems, or services to automate quality system This software is not to be confused with product software – that is, software that runs as part of a medical device.  Medical device in this context could be custom hardware devices or Software as a Medical Device (SaMD)....
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Remember the 2005 guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices? In 2020 that guidance is as relevant as ever, and it can be useful to review what we know about the FDA’s expectations regarding Level of Concern (LOC) in medical devices. LOC is important if for no...
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March 2, 2020 Excerpts from a warning letter of interest to software professionals: 1.b. Validation of device software is inadequate and is incomplete. Specifically, your firm did not conduct or document the results of software requirement specification and software design specification in your software verification and validation report for your Class II Swaive Thermometer. The...
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ISO 14971 Risk Analysis Identifying safety risks in medical devices is a challenging and laborious process.  The process standard, ISO 14971, is a systematic, total product risk management lifecycle process to identify, control, and evaluate risk, where risk is defined as the combination of severity of the harm (to people, property, or environment) and probability...
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The US Defense Advanced Research Projects Agency (DARPA) have released a solicitation for the “Automated Rapid Certification of Software (ARCOS)” project.  The project goal is to automate system risk assessment based on software assurance.  The project recognizes that current practices in this area rely upon human judgement which can be prone to error but also...
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Advanced Botanical Consulting & Testing Inc dba ABC Testing Product: Drugs Date: 6/11/19 CMS Number: 572991 The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, Advanced Botanical Consulting and Testing Inc. dba ABC Testing (FEI 3003693795) at 1169 Warner Ave, Tustin, California, from November 1 to 13, 2018. This warning letter summarizes...
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Glanced through the latest FDA warning letters today.  From the FDA Medical Device & Radiological Health Operations West/Division 3 I see the inspector pointing out “This design validation also fails to include software validation [emphasis mine] to assure software will perform as intended and will not prevent safe operation by the user.”   Of course this is...
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“Could this be a problem with the label printing software?” – Brian Pate Company: Smiths Medical ASD Inc. Date of Enforcement Report 10/10/2018 Class III: PRODUCT First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style Recall Number: Z-0071-2019 REASON “Manufactured” and “Use By” labels are transposed incorrectly suggesting the...
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Software-based medical devices tend to develop more quickly than typical hardware-based medical devices; so, in response, the FDA has turned to an agile regulatory model for software as a medical device (“SaMD”). The FDA describes the Software Precertification Program as a voluntary pathway, with tailored assessments of the safety and effectiveness of software technologies. Rather...
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I don’t even really like to use the word retrospective
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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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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:  TBD

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

Registration Link:

TBD

 


 

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: March 7 & 28, 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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