DHFの原則
各機種の設計に対して設計履歴ファイル(DHF)を作成し保存すること。
DHFには、計画書で定義されている設計に関するすべての記録を保持すること。
設計開発は、設計計画書に基づいて実施されたことをDHFの内容により証明できること。
DHFは、設計のInput、Output、Design Review、Verification、Validationの各時点での成果物を登録すること。
Input、Output、Design Review、Verification、Validation結果を承認すること。
FDAのワーニングレターの事例
貴社は設計が承認された設計計画および21 CFR 820の要求に従ってなされたということを示すための必要な記録を含み、参照するための設計履歴ファイル(DHF)を確立および維持していない。
- 参考
21 CFR Part820 Quality System Regulation, FDA 1997
Design Control Guidance For Medical Device Manufacturers, FDA 11 March,1997
FDA査察対応設計管理手順書サンプル
イーコンプライアンスでは、FDAが要求する設計管理に対応した、規程、手順書、様式のサンプルを販売しています。
ぜひご購入をご検討下さい。
I am regular visitor, how are you everybody? This piece of writing posted at this web page is genuinely nice.
Very nice post. I just stumbled upon your blog and wanted to say
that I’ve truly enjoyed browsing your blog posts. After
all I’ll be subscribing to your rss feed and I hope you
write again very soon!
Good day very cool blog!! Man .. Beautiful .. Superb .. I’ll
bookmark your blog and take the feeds also? I’m glad to seek out numerous helpful info here within the submit, we’d
like work out more strategies on this regard, thanks for sharing.
. . . . .
I think this is one of the most significant information for me.
And i am glad reading your article. But should remark
on few general things, The site style is great, the articles is
really nice : D. Good job, cheers
This is a topic that is close to my heart… Best wishes!
Where are your contact details though?
I am sure this post has touched all the internet visitors, its really really nice post on building
up new weblog.
Magnificent website. Plenty of helpful information here.
I’m sending it to a few buddies ans also sharing in delicious.
And obviously, thanks to your sweat!
I needed to thank you for this wonderful read!! I certainly enjoyed every bit of it.
I’ve got you book-marked to look at new stuff you post…
It’s very easy to find out any matter on net as compared to books, as I found this post at this website.
This article offers clear idea designed for the new
viewers of blogging, that actually how to do blogging.
Do you mind if I quote a couple of your articles as long
as I provide credit and sources back to your site?
My blog site is in the exact same niche as yours and my visitors
would genuinely benefit from some of the information you present here.
Please let me know if this okay with you. Thanks a lot!
Hey there! I know this is sort of off-topic but I had to ask.
Does running a well-established website such as yours require a
lot of work? I am brand new to writing a blog but I
do write in my diary daily. I’d like to start a blog so I
can easily share my personal experience and thoughts online.
Please let me know if you have any suggestions or tips for brand new aspiring bloggers.
Thankyou!
This is very interesting, You’re a very skilled blogger.
I have joined your rss feed and look forward to seeking more
of your great post. Also, I’ve shared your website in my
social networks!
Howdy just wanted to give you a brief heads up and let you know a few
of the images aren’t loading properly. I’m not sure why
but I think its a linking issue. I’ve tried it in two different web browsers
and both show the same results.
Superb post but I was wondering if you could write a litte more on this
topic? I’d be very thankful if you could elaborate a little bit more.
Thanks!
Excellent article! We will be linking to this great post on our site.
Keep up the great writing.
If some one wants expert view about blogging and site-building afterward i propose him/her to go to see this blog, Keep up the good work.
Greetings from Idaho! I’m bored to death at work so I decided
to check out your site on my iphone during lunch break.
I enjoy the knowledge you present here and can’t wait to take
a look when I get home. I’m surprised at how quick your blog loaded on my cell phone
.. I’m not even using WIFI, just 3G .. Anyways, wonderful
site!
Incredible story there. What occurred after? Good luck!
I blog often and I seriously appreciate your content.
Your article has truly peaked my interest. I am going to bookmark your site and keep checking for new details about once a week.
I subscribed to your Feed too.
Hi, I think your site might be having browser
compatibility issues. When I look at your
blog site in Chrome, it looks fine but when opening in Internet Explorer, it
has some overlapping. I just wanted to give you a quick heads
up! Other then that, wonderful blog!
Hello there! Do you use Twitter? I’d like to follow you if that would
be okay. I’m undoubtedly enjoying your blog and look forward to
new updates.
My brother recommended I might like this website.
He was entirely right. This post actually made my day.
You can not imagine simply how much time I had
spent for this information! Thanks!
You actually make it appear really easy together with your presentation but I find this matter to
be actually something which I feel I’d never understand.
It seems too complicated and extremely large for me.
I am looking forward in your next publish, I
will attempt to get the dangle of it!
Excellent blog here! Also your website loads up very fast!
What web host are you using? Can I get your affiliate link to your host?
I wish my site loaded up as quickly as yours lol
Good way of describing, and nice post to get facts concerning my presentation topic, which i am going to convey in institution of higher education.
Hi there, I found your website via Google even as looking for a similar subject, your website came up, it seems to be great.
I have bookmarked it in my google bookmarks.
Hello there, simply turned into aware of your blog through Google,
and found that it is really informative. I’m going to watch out for brussels.
I’ll appreciate in the event you continue this in future.
Lots of people shall be benefited from your writing.
Cheers!
Whats up are using WordPress for your blog platform?
I’m new to the blog world but I’m trying to get started and create my own.
Do you require any html coding knowledge to make your own blog?
Any help would be greatly appreciated!
Good write-up. I definitely appreciate this site. Thanks!
Having read this I believed it was rather enlightening.
I appreciate you finding the time and effort
to put this informative article together. I once again find myself
personally spending a lot of time both reading and commenting.
But so what, it was still worthwhile!
I just could not leave your web site before suggesting that I
extremely loved the usual information a person supply for your guests?
Is gonna be back ceaselessly to inspect new posts
Very good information. Lucky me I came across your website by chance
(stumbleupon). I have bookmarked it for later!
Write more, thats all I have to say. Literally,
it seems as though you relied on the video to make your point.
You obviously know what youre talking about, why waste your intelligence on just posting videos to your weblog
when you could be giving us something enlightening to read?
Hi! This post could not be written any better! Reading through this post reminds me of
my previous room mate! He always kept talking about this.
I will forward this article to him. Fairly certain he will have a good read.
Thank you for sharing!
you’re truly a excellent webmaster. The web site loading speed is incredible.
It seems that you are doing any unique trick.
Moreover, The contents are masterwork. you’ve performed a great task in this topic!
This is a topic that’s near to my heart… Cheers!
Where are your contact details though?
I am regular reader, how are you everybody?
This article posted at this website is truly pleasant.
Hmm is anyone else having problems with the pictures on this blog loading?
I’m trying to find out if its a problem on my
end or if it’s the blog. Any responses would be greatly appreciated.
I just couldn’t depart your website prior to suggesting that I extremely loved
the standard information an individual provide in your visitors?
Is gonna be back often to check up on new posts
Hello, its good paragraph concerning media print, we
all be aware of media is a great source of information.
If you are going for finest contents like me,
just go to see this site every day for the reason that it provides quality
contents, thanks
Hi! I know this is kind of off topic but I was wondering if you knew where
I could find a captcha plugin for my comment form? I’m
using the same blog platform as yours and I’m having difficulty finding one?
Thanks a lot!
It’s an remarkable article in favor of all the online users; they will take advantage from it I am sure.
Hello there! Quick question that’s entirely off topic.
Do you know how to make your site mobile friendly?
My website looks weird when viewing from my iphone.
I’m trying to find a template or plugin that might be able to resolve this problem.
If you have any recommendations, please share. Appreciate it!
Hi, i believe that i saw you visited my web site so i came to return the
desire?.I am attempting to find issues to enhance my site!I assume its ok to use a few of your ideas!!
I couldn’t refrain from commenting. Perfectly written!
Because the admin of this website is working, no question very rapidly it will be
famous, due to its quality contents.
When I originally commented I clicked the “Notify me when new comments are added” checkbox and now
each time a comment is added I get several e-mails with the same comment.
Is there any way you can remove me from that service?
Thanks a lot!
It’s remarkable in favor of me to have a website,
which is valuable designed for my knowledge. thanks admin
obviously like your website but you need to check the spelling on quite a few of your posts.
Many of them are rife with spelling issues and I to find it very troublesome to tell the reality nevertheless I will definitely come
back again.
Hello guys , keep up the good work Get more info
It’s everything about simplicity and elegance. I love it. Keep up the good work.
http://onnuri.korwn.kr/bbs/board.php?bo_table=free&wr_id=79390
Great post.
I go to see each day some blogs and sites to read content, except this webpage provides quality based content.
https://pub.ezen-i.com/bbs/board.php?bo_table=free&wr_id=116442
Howdy would you mind stating which blog platform you’re working with?
I’m looking to start my own blog in the near future but I’m
having a hard time making a decision between BlogEngine/Wordpress/B2evolution and Drupal.
The reason I ask is because your design and style seems different then most blogs and I’m looking for
something unique. P.S My apologies for being off-topic but I had to
ask!
Hello there I am so thrilled I found your blog, I really found you by accident, while I was searching on Digg for something else, Regardless
I am here now and would just like to say thanks for a fantastic post and a all
round enjoyable blog (I also love the theme/design), I don’t have time to
browse it all at the minute but I have saved it and also included your RSS feeds, so when I have time I will be back
to read a great deal more, Please do keep up the awesome jo.
obviously like your web site but you have to take a look at the spelling on quite a few of your posts.
A number of them are rife with spelling problems and I to find it very troublesome to tell the
truth nevertheless I will certainly come back again.
I know this if off topic but I’m looking into starting my own blog and
was curious what all is required to get setup? I’m assuming having a blog like
yours would cost a pretty penny? I’m not very internet savvy so I’m not 100% certain. Any recommendations
or advice would be greatly appreciated. Thank you
Very good site you have here but I was wondering if you knew of any forums
that cover the same topics talked about here? I’d really love to be a part of community where I
can get suggestions from other knowledgeable individuals that share the same interest.
If you have any suggestions, please let me know.
Kudos!
fantastic put up, very informative. I ponder why the opposite experts of this sector don’t notice this.
You should continue your writing. I’m sure, you have a huge readers’
base already!
https://www.unotravel.co.kr/contents/board.php?bo_table=adminPhoto&wr_id=1832
https://saerodental.com/bbs/board.php?bo_table=free&wr_id=1127895