Jim hello have a few questions for you How can I direct message you
How to keep up to date with NEW standards
- Thread starter jozy80
- Start date
Sorry, but I don't do 1:1 stuff here. It's better to ask your question(s) in the forums so that others might benefit.
indubioush
Ah ha!
If you are med device, do an annual review of FDA consensus revs. You can filter by date of entry and only review standards added in the previous year. Recognized Consensus Standards: Medical Devices
For ISO and IEC stuff, I keep an eye on updates from the relevant technical committees.
For the FDA, I look at consensus standard lists.
For the EU, I look at harmonised standards lists.
For the UK, I look at designated standards lists.
I also follow the CDRH news, Europa News and MHRA News for new guidance or upcoming regulatory changes.
I also follow IMDRF News, Team NB News (also Team AB once they are set up), Emergo News, Regulatory Rapporteur, RAPS Regulatory Focus, ABHI Resources MedTech Europe and GHWP/AHWP.
I have each of the pages assigned to a Distill account (other page trackers are available) and check them every few days; however, I work as a consultant and not under ISO 13485, so I don't have to validate my software. If I did, instead of validating Distill, I would just open each of the webpages listed above once per week, look for any relevant news, then use a spreadsheet or similar to record what was relevant and any improvement actions I added to my improvement log, then sign off the update to the spreadsheet.
For the FDA, I look at consensus standard lists.
For the EU, I look at harmonised standards lists.
For the UK, I look at designated standards lists.
I also follow the CDRH news, Europa News and MHRA News for new guidance or upcoming regulatory changes.
I also follow IMDRF News, Team NB News (also Team AB once they are set up), Emergo News, Regulatory Rapporteur, RAPS Regulatory Focus, ABHI Resources MedTech Europe and GHWP/AHWP.
I have each of the pages assigned to a Distill account (other page trackers are available) and check them every few days; however, I work as a consultant and not under ISO 13485, so I don't have to validate my software. If I did, instead of validating Distill, I would just open each of the webpages listed above once per week, look for any relevant news, then use a spreadsheet or similar to record what was relevant and any improvement actions I added to my improvement log, then sign off the update to the spreadsheet.
Enghabashy
Quite Involved in Discussions
*Follow up standards is one of document & information monitoring ; it's external doc. / Info,
**the best process that I designed is making list of all standards used; the lists are scheduled to follow up for each standard at least every 3 months ; it's easy to follow up by internet & checking ISO,BS,EN,UL---etc STDs library ; EU directives are free & should be part of list if applicable '
*** many of STDs should be marked / identified by " FOR INFORMATION ONLY "--, that's good to keeping it without mandatory updating if applicable
**** many of STDs parties are producing free service just you buy standard , UL as example provide notification as updating STDs that covering your previous deals
**the best process that I designed is making list of all standards used; the lists are scheduled to follow up for each standard at least every 3 months ; it's easy to follow up by internet & checking ISO,BS,EN,UL---etc STDs library ; EU directives are free & should be part of list if applicable '
*** many of STDs should be marked / identified by " FOR INFORMATION ONLY "--, that's good to keeping it without mandatory updating if applicable
**** many of STDs parties are producing free service just you buy standard , UL as example provide notification as updating STDs that covering your previous deals