Recent Topics
@Jeremiah Genest
Thank you for sharing with the Medical Device Division! Best wishes with this event!

@Monica Deo
I have both certifications. The BoK covers many aspects for both Pharma and Med Devices and is very ...

@Monica Deo
Hello Monica, I would also include risk.
If things are one off or infrequent and easily corrected, with ...

Sampling plans must be statistically valid. The best way to do this is thru standards such as those available thru ...


Hi Alireza,
While there is no definitive guidance on sampling plans from the FDA, have used the following for ...


Here is a list of all FDA approved algorithms and devices - might help identify use in hospitals
Forum Topic List
-
- Topic
- Replies
- Views
- Last Post
-
-
FD&C Poster Share in Boston - Feburary 2023
by Jeremiah Genest - Jan 20, 2023 2:56 pm - 1
- 0
-
Re: FD&C Poster Share in Boston - Feburary 2023
by Lisa Grosskopf
Jan 20, 2023 9:04 pm
-
FD&C Poster Share in Boston - Feburary 2023
-
-
Pharmaceutical GMP Professional vs. CMDA certification
by Monica Deo - Nov 16, 2022 11:28 am - 1
- 0
-
Re: Pharmaceutical GMP Professional vs. CMDA certific...
by Ajit Basrur
Dec 24, 2022 8:02 pm
-
Pharmaceutical GMP Professional vs. CMDA certification
-
-
New Addition
by Steven Schuelka - Jul 11, 2022 9:01 am - 0
- 0
-
New Addition
by Steven Schuelka
Jul 11, 2022 9:01 am
-
New Addition
-
-
Tell Us a Story
by Norm Howe - Jun 1, 2022 12:43 pm - 0
- 0
-
Tell Us a Story
by Norm Howe
Jun 1, 2022 12:43 pm
-
Tell Us a Story
-
-
Looking for help with a De Novo medical device submission
by Norm Howe - Mar 2, 2021 10:52 am - 2
- 0
-
Re: Looking for help with a De Novo medical device submis...
by David Rothkopf
Apr 27, 2022 12:18 pm
-
Looking for help with a De Novo medical device submission
-
-
Poka Yoke Awareness
by Norm Howe - Mar 24, 2022 10:10 am - 0
- 0
-
Poka Yoke Awareness
by Norm Howe
Mar 24, 2022 10:10 am
-
Poka Yoke Awareness
-
-
Artificial Intelligence Applications or medical device in healthcare
by Rana Yanis - Oct 30, 2021 7:55 am - 1
- 0
-
Re: Artificial Intelligence Applications or medical d...
by Isabel Allen
Oct 31, 2021 3:33 pm
-
Artificial Intelligence Applications or medical device in healthcare
-
-
ISO 9001 Future Consideration
by Lisa Grosskopf - Jun 3, 2021 9:40 pm - 0
- 0
-
ISO 9001 Future Consideration
by Lisa Grosskopf
Jun 3, 2021 9:40 pm
-
ISO 9001 Future Consideration
-
-
Acceptability of FAI item with nonconformance?
by Lisa Grosskopf - May 5, 2021 9:53 pm - 1
- 0
-
Re: Acceptability of FAI item with nonconformance?
by Veronique Boucher
May 27, 2021 4:29 pm
-
Acceptability of FAI item with nonconformance?
-
-
off-the-shelf-suppliers
by Lisa Grosskopf - May 5, 2021 9:51 pm - 0
- 0
-
off-the-shelf-suppliers
by Lisa Grosskopf
May 5, 2021 9:51 pm
-
off-the-shelf-suppliers