Software to Manage Compliance to ISO 14971 (Medical Device Risk Management).

T

TJG954 - 2009

#1
Can anyone recommend a program we can purchase to lead us through 14971 compliance?

Thanks for your help.
Ted

:thanks:
 
Elsmar Forum Sponsor
T

TJG954 - 2009

#3
Thank you for the reply Mmantunes. I was starting to think no one was dealing with 14971.

:lmao:
 
S

sar727

#5
Complaince to ISO 14971 means streamlinining your risk management process and try to integrate/roll up all risk to have visibility into higher risks across the business unit/organization.

There are many software companies out there who might help. I have used Dyadem for the same.
 

Stijloor

Staff member
Super Moderator
#7
I am with a very small company...is Dyadem's software prohibitively expensive?
"Expensive" is a relative term. You should weigh the costs associated with a product/device failure against the investment of acquiring the appropriate software. I am sure that the software companies you should consider can provide you with the data you need to help make the best decision.

Stijloor.
 
T

TDX-2 - 2011

#8
OK...I deserved that...poorly worded question asked too late in the day.

Thanks anyway.
 

Stijloor

Staff member
Super Moderator
#9
OK...I deserved that...poorly worded question asked too late in the day.

Thanks anyway.
No, I don't think the question was poorly worded. ;)

I just hope that you can find the info that will help you to move forward with selecting the software you may need. That's all. :agree:

Stijloor.
 
W

Watchwait

#10
Specific Question r.e. ISO 14972:2007...

This revision of the document does not include the "Ability to Detect Defect" column in it's matrix. It only addresses the product of "Severity" & "Frequency". A typical FMEA includes an assessment of the ability to detect any given defect & includes this factor in the Risk Priority Number. Stated another way, an FMEA integrates the impact of Severity, Frequency & Detection. ISO 14971:2007 seems to have done away with the "Detection" component. We are really struggling with this issue & would appreciate any input from the group in this regard. Tks!
 
Thread starter Similar threads Forum Replies Date
M Looking for software to manage ISO 9001:2008 system Quality Assurance and Compliance Software Tools and Solutions 4
E Software that will manage my APQP documents Quality Assurance and Compliance Software Tools and Solutions 9
Marc What software (if any) do you use to manage your quality system? Quality Assurance and Compliance Software Tools and Solutions 57
J Software or template to manage first piece, in process and final inspection reports Software Quality Assurance 2
E Quality Software - Who uses software to manage your Quality System? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q Software/Tools to Manage ISO 12207 Audit of Software Development Process Software Quality Assurance 4
Q Software solution to manage APQP and PPAP Quality Assurance and Compliance Software Tools and Solutions 3
Y Quality Assurance Software to manage ISO 9001 - Need advice Quality Assurance and Compliance Software Tools and Solutions 10
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
Y Software updates considered servicing (7.5.4) ISO 13485:2016 - Medical Device Quality Management Systems 4
S How to perform verification of the Statistical Analysis Software? Qualification and Validation (including 21 CFR Part 11) 2
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
L Micro-Vu InSpec Software Program Qualification and Validation (including 21 CFR Part 11) 6
A For software change - New Channel of interoperability CE Marking (Conformité Européene) / CB Scheme 4
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
C SharePoint Contract Management Software General Information Resources 0
gramps What do you think about automated QA testing For software app industry? Misc. Quality Assurance and Business Systems Related Topics 5
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
U API Spec Q1 - 5.6.1.2 C (3) - Design software Oil and Gas Industry Standards and Regulations 3
B Complaint Records - Accessing records on Easy Track Software Records and Data - Quality, Legal and Other Evidence 3
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 0
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
H Software Validation for FFS Packaging Machine Qualification and Validation (including 21 CFR Part 11) 1
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 1
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3
D Safety data sheets software REACH and RoHS Conversations 2
N What are the software audit and control steps Reliability Analysis - Predictions, Testing and Standards 2
N Validating Software before getting approved as Class 2 device US Food and Drug Administration (FDA) 5
M Clinical Decision Support Software Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Missing 1m visual alarm signal in case of software/display failure, mitigation? ISO 14971 - Medical Device Risk Management 3
B Software service provider as critical supplier ISO 13485:2016 - Medical Device Quality Management Systems 5
S Asterisk in DOE minitab software Using Minitab Software 23
M Surgical angle measurement guide device with an application software Medical Device and FDA Regulations and Standards News 1
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
bruceian Software Quality Metrics Software Quality Assurance 11
optomist1 How Secure Are Our Software Systems Software Quality Assurance 7
M 'Active' device? Software/laptop with attached camera 'looking' at passive metal probe EU Medical Device Regulations 3
D Software validation team Misc. Quality Assurance and Business Systems Related Topics 3
O Any info on release date of FDA “Computer Software Assurance for Manufacturing and Quality System Software” document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
L Radiology software Class I exemption Medical Device and FDA Regulations and Standards News 3
O Software for comparing text of PDF files Contract Review Process 2
J Implementing an ISO 13485 QMS Software ISO 13485:2016 - Medical Device Quality Management Systems 6
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 2
M Recurrent event analysis software (python) General Auditing Discussions 2
Y UL 1998 Standard: software classes Software Quality Assurance 0

Similar threads

Top Bottom