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Post Market Surveillance Standard

Ellison

Starting to get Involved
#1
Good Morning,
We are working on creating a Proactive pms data collection survey for safety and effectiveness. Is there a ISO standard that covers data collection, customer survey or PMS system. In general? Would ISO 14155 be any help in determining a sample size?

I know all over the place here.

Thanks in Advance
Ellison
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#2
Good Morning,
We are working on creating a Proactive pms data collection survey for safety and effectiveness. Is there a ISO standard that covers data collection, customer survey or PMS system. In general? Would ISO 14155 be any help in determining a sample size?

I know all over the place here.

Thanks in Advance
Ellison
Nope. I would suggest reading some books on research methods for social sciences (there's even some very good specific to sampling).

(from a post I made on Linkedin: Reviewing concepts for the medical device post-market surveillance (PMS) training and that I am going to present this week. The PMS process is nothing more than a research project focused on answering specific questions related to the product, with the objective of defining actions based on the research results. To do so, it must be planned and designed as a research project, with fundamental questions that the company wants to answer, use data research methods (most of them from the social sciences field), analyze the data and create a report of (the PMS report) with the analysis and conclusion on which predefined actions (from the planning) shall be carried out. Some of the literature I use as a basis for explaining the process: - An Introduction to Qualitative Research - A great introduction to research concepts and methods - Research Methods in Social Relations - A basic guide to applying research in the social sciences - Doing Business Research and Management: An Essential Guide to Planning Your Project - An introductory guide to the application of research in business - Researching Business and Management: The Roadmap For Success - A more detailed guide to the application of research in business)
 

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Ellison

Starting to get Involved
#4
Marcelo,
Thank you! I do have one question and this is out of pure ignorance because this is the first time i’ve Really been involved in this type of activity. Do you need to show how you got to your questions? Like how they relate back to your device intended use and IFU. Is this something that the NB would expect to see?

Thanks
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#5
Marcelo,
Thank you! I do have one question and this is out of pure ignorance because this is the first time i’ve Really been involved in this type of activity. Do you need to show how you got to your questions? Like how they relate back to your device intended use and IFU. Is this something that the NB would expect to see?

Thanks
Yes, it would be good practice (in particular if you treat the PMS system a research project, which I think is the best way to do it).

I just put some of the things I put on Linkedin in a blog post, it will be available in the Cove in a while (it's here anyway: Creating a post market surveillance (PMS) system for medical devices – Part 1 – Medical Device Expert News).
 
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