Question
I would like to know if some of you have issues with this procedure ? What is your Notified Body and does it still accept OBL procedure for CE marking ? I think that is a huge concern for many Medical Device companies and it deserves a discussion. so...
The most important document in a Design History File (DHF) should also be the first document you create when you are developing a new medical device--the design plan. However, I find a number of companies that are preparing to submit regulatory submi...
Shanshan (Samantha) Chen (ASQ CQA)
RA/QA professional in Medical devices industry, seeking to new opportunity.
August 2016
Do anybody know that is there any labelling requirement for medical device’s Wi-Fi function in Canada? I check the label regulation and they did not mention Wi-Fi, thanks!source: https://www.linkedin.com/groups/2070960/2070960-6176002121310175232
I was talking with a client in the medical device design & development space. He and every one of his competitors claim they are ISO:13485 certified and have many experts. They boast their client roster, show their portfolio, and promise quality/spee...
Hey med developers, I was thinking about all the work that goes into medical devices and how much resistance there can be to design thinking so much of the time. It has become extremely popular in consumer device design, but not so quickly accepted w...
Nathalie Baudry
Freelance Medical/Scientific writer - Translator - Project management chez Freelance
June 2016
In our company we produce cosmetics and some of them are going to become medical devices (class I and IIa). I would like to know if some of you have experience with this kind of changes. Are cosmetic GLP and INCI list mandatory for these MD? Thanksso...
Is it mandatory to have GS1 GTIN barcoding on medical device? I understand US FDA has made UDI mandatory, but for a company which is not targeting US market is it good to have a GS1 GTIN barcoding in place. source: https://www.linkedin.com/groups/786...
Do you control design changes differently during pre-transfer segment of design and development project, during design transfer and after product release?All changes must be reviewed and approved, but how much control is necessary prior to verificati...
Goodmorning all, I have a question about the use of the IVD symbol on in vitro diagnostic products in USA. The IVD symbol as defined in ISO 15223 standard should be used to indicate "a medical device that is intended to be used as an in vitro diagnos...
Is anyone aware of the FDA guidance documents to say what medical devices require specialized instructions for disposal? I’m not talking about ones with obvious hazards such as implantables or ones with sharps, but simple Class I single-use devices. ...
