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Dear all,
Hope you can help me out on this one. The CSDT format for Medical Devices asks for "Instructions for Use (IFU)" of the medical device. In our case, the medical devices we are pretending to submit due to their nature they don't nee from an Instructive...
Started by LQ. Fanny Lozano on
, 5 posts
by 4 people.
Answer Snippets (Read the full thread at elsmar):
Hope that someone who already submitted medical devices on those countries.
For Medical Devices CSDT is defined in Guidance GN-17 for general devices, and GN-18 for IVDs or not an IFU format.
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Hello All!
I am currently an independent rep selling implants and am looking for a company which I can stay with long term without having to invest my own money for someone else to make the big bucks! I'm also interested in a company that has integrity...
Answer Snippets (Read the full thread at cafepharma):
I would look at some of the bigger medical device companies (Medtronic, Stryker are in marketing for, but....
I would look at some of the bigger medical device companies (Medtronic, Stryker of 1.5 to 2 years.
Of 1.5 to 2 years.
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Does anyone know what this vintage medical device was used for? http://www.ebay.com/itm/120840530161?ssP…
Thanks!
Started by mcrcrazedfan on
, 4 posts
by 4 people.
Answer Snippets (Read the full thread at yahoo):
Cannot fathom out.
Looks like some device for opening the vaginal entrance for medical examination.
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Ask your Facebook Friends
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Hi,
Our device a medical device based on borderline criteria and has been tested using standards 61010-1-2001 and 60601 2nd edition. We are currently in the process of obtaining an EC certificate. Should we retest to 61010-1-2010? Also, 61010-1 is not...
Started by spectra123 on
, 4 posts
by 3 people.
Answer Snippets (Read the full thread at elsmar):
If your device is a electrical medical device then the harmonized standard to use to show compliance with the Medical Device Directive is 60601-1 need to use....
Decision, especially as 61010 comes in under the CB Scheme .
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Does anyone have a template for a medical device APQP? I do not wish to reinvent the wheel. If someone can share one that is oriented toward medical component parts that I can then modify, I would be most grateful.
Started by WisdomseekerSC on
, 4 posts
by 3 people.
Answer Snippets (Read the full thread at elsmar):
Thanks!.
Checklist and data capture templates? Please would you share if you get a checklist template? I'm working on the same thing .
Rob Nice task (project stage) timeline chart.
Feel free to change this one how you please.
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I know there´s some Covers working for software-only medical device manufacturers (when the manufacturer produces only medical devices which are software).
Have you had any problem when implementing ISO 13485? For example, are there clauses/requirements...
Started by Marcelo Antunes on
, 5 posts
by 2 people.
Answer Snippets (Read the full thread at elsmar):
We had problems when setting up the standard deem some requirements... .
In Clause 7 of this International Standard is (are) not due to the nature of the medical device(s :-)
Software in medical devices is the heart of my job.
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Hi!
I'm new to this forum and I'm glad to find such a rich information source related to IEC 62366. Since I am software risk manager I am interested in the software aspects of IEC 62366. But the examples in the standard itself are not so related to medical...
Started by sparvhok on
, 8 posts
by 5 people.
Answer Snippets (Read the full thread at elsmar):
They both show with using standards on....
Annex E of 60601-1-6:2006 is the "same" as Annex H of 62366 .
Software is to used in conkunction with another medical device?) Hi sparvhok,
As Marcelo says to a general medical device.
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All you glorified paragard reps - YOU are JUST pharma reps. A true medical device rep is selling in the OR, working with surgeons...on spines, hips, knees, etc.. A TRUE device rep is a 1099 employee making $350+ year. They do not have glorified micro ...
Answer Snippets (Read the full thread at cafepharma):
Go to company boards and then....
The medical device companies you referenced ARE on Cafepharma.
Paragard reps ARE more a procedural technique.
Paragard Reps are NOT traditional device reps.
Paragard IS a medical device.
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Hi everyone,
Does any one know if it is mandatory to include a printed version of the users manual with a medical device? If so, I would like to know where it is written.
Also, is there a difference between EU and US regulation on this mater?
Thanks!
...
Started by shimonv on
, 4 posts
by 3 people.
Answer Snippets (Read the full thread at elsmar):
For CE mark, as long as you are compliant with essential requirements #13.x in annex I ... .
For FDA, I can't answer.
Products were FDA cleared and CE marked.
Hi shimon,
I worked a few years ago in a company which didn't ship printed IFU with its products .
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Hello,
I am new to the forum and relatively new to Canadian Medical Device regulations and requirements. I find the forum very informative.
I have browsed Health Canada website searching for amendments to SOR/98-282 since it's implementation. What I am...
Started by PinoyC on
, 8 posts
by 5 people.
Answer Snippets (Read the full thread at elsmar):
Specifically, the ISO 13485 to manufacturers who already held ....
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