Soft Computer Consultants Blood Bank Computer SW

Soft Computer Consultants 12/4/98 Blood Bank Computer SoftwareDESIGN CONTROLS

1) Failure to establish and maintain plans that describe or reference the design and development activities, and define responsibility for implementation including the plans that describe the interfaces with different groups that provide input to the design and development process [21 CFR 820.30(b)].

2) Failure to establish and maintain a Design History File (DHF) containing or. referencing records necessary to demonstrate that the design was developed in accordance with the approved design plan and the Design Control requirements [21 CFR 820.30(j)].

3) Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses including testing of production units under actual or simulated use conditions. Failure to document the results of the design validation in the DHR. For example, Softbank II application software, Release 1.21, dated 7/14/98 was not validated using the original protocol. [21 CFR 820.30(g)]

4) Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review and approve of design changes before their implementation. For example, quality assurance and approval of design changes did not occur before release and implementation of Softbank II software. [21 CFR 820.30(i)]

7) Failure to establish and maintain procedures to control all documents in that, obsolete and/or unapproved standard operating procedures (SOP) are referenced in approved SOPs [21 CFR 820.40]. For example:

a. SOP 1053A, entitled Softbank II Change Control, which is an approved procedure, references use of unapproved procedure, SOP 1012;

b. SOP 1078, entitled Configuration Management, which is an approved procedure, references use of unapproved and/or obsolete procedures, SOP 1081, SOP 1011, and SOP 1024B; and

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.