【医療機器企業リスクマネジメント】ISO 14971:2019逐条解説

医療機器企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。 
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。 

医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。 
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。 

昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。 
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。 
それでは、医療機器の安全が確保できず、また回収(改修)も減少しません。 
そのためには、リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。 

本セミナービデオでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。

お役立ち動画

https://www.youtube.com/watch?v=k7sVXpUKSzE

関連商品

[blogcard url=”https://ecompliance.co.jp/SHOP/191121P.html” title=”医療機器企業におけるリスクマネジメントセミナー” content=”医療機器企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。

医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。

昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。
それでは、医療機器の安全が確保できず、また回収(改修)も減少しません。
そのためには、リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。

本セミナービデオでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/EL-008.html” title=”【セミナービデオ】医療機器企業におけるリスクマネジメントセミナー” content=”医療機器企業にとって、リスクを管理することは非常に重要です。しかしながら、リスクマネジメントは難解です。
医療機器業界では、欧州が先行し、90年代からIOS-14971が制定されました。

医療機器には何がしかのリスクが潜んでいます。リスク分析の結果は、設計管理のインプットとなります。
医療機器事故は、ユーザの意図した利用と設計者の思想のギャップによって起こるとされています。

昨今では、ユーザビリティを含め、合理的な誤使用を予測したリスク分析が求められています。
演者は多くの医療機器企業においてリスクマネジメントの指導を行ってきましたが、各社ともに我流で実施していることが多いようです。
それでは、医療機器の安全が確保できず、また回収(改修)も減少しません。
そのためには、リスクマネジメントの基本的な考え方と規制当局の期待を十分に理解しなければなりません。

本セミナービデオでは、難解なリスクマネジメントを初心者にもわかりやすく解説いたします。”]

[blogcard url=”https://ecompliance.co.jp/SHOP/MD-QMS-026.html” title=”【ISO 14971:2019対応】リスクマネジメント規程・手順書・様式” content=”ISO14971:2019に沿った形のリスクマネジメント規程・手順書・様式です。
医療機器設計におけるリスク分析は、ISO-14971に従って実施されています。
リスクマネジメント実施のための手順や様式を整えておかなければなりません。”]

[blogcard url=https://xn--2lwu4a.jp/qms-md/ title=”QMS(手順書)ひな形 医療機器関連” ]


Related post

Comment

  1. Pretty nice post. I just stumbled upon your weblog and wished to say that I have truly enjoyed
    surfing around your blog posts. In any case I’ll be subscribing to your
    rss feed and I hope you write again very soon!

  2. I need to to thank you for this great read!! I absolutely loved every
    bit of it. I’ve got you saved as a favorite to check out new
    things you post…

  3. I every time used to study post in news papers but now as I am a user of
    web so from now I am using net for articles or reviews, thanks to web.

  4. Normally I don’t learn post on blogs, but I wish to say that this write-up very forced me to
    take a look at and do so! Your writing style has been amazed me.
    Thanks, quite nice article.

  5. My family always say that I am wasting my time here at web, however I
    know I am getting know-how daily by reading such pleasant content.

  6. You can definitely see your skills in the article you
    write. The sector hopes for even more passionate writers such as you who aren’t afraid
    to say how they believe. Always follow your heart.

  7. Magnificent beat ! I would like to apprentice while you amend your site, how could i subscribe for a blog site?
    The account aided me a acceptable deal. I had been tiny bit acquainted of this your broadcast offered bright clear concept

  8. hello there and thank you for your information – I have
    definitely picked up something new from right
    here. I did however expertise several technical points using this web site, as I
    experienced to reload the web site lots of times previous to I could get it to load properly.
    I had been wondering if your web host is OK? Not that I’m complaining, but slow loading instances times
    will very frequently affect your placement in google and can damage your high
    quality score if ads and marketing with Adwords. Anyway I am adding this RSS to my email and can look out for
    a lot more of your respective fascinating content. Ensure that you update this again very soon.

  9. Excellent weblog right here! Also your web site loads up very fast!
    What host are you using? Can I get your affiliate hyperlink to your host?
    I desire my website loaded up as fast as yours lol

  10. It’s truly very complicated in this busy life to listen news on Television, therefore I simply use web for that
    purpose, and take the hottest news.

  11. I blog quite often and I seriously thank you for your information.
    Your article has really peaked my interest.
    I am going to bookmark your website and keep checking for new information about once per week.
    I subscribed to your RSS feed too.

  12. When someone writes an piece of writing he/she maintains the thought of a user in his/her brain that how a user can know it.

    Thus that’s why this article is amazing. Thanks!

  13. It’s amazing in favor of me to have a web site,
    which is helpful designed for my knowledge. thanks admin

  14. 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 people from that service?
    Thanks!

  15. Hi, i think that i saw you visited my blog thus i got here to go back the choose?.I’m attempting to
    to find things to improve my web site!I guess its adequate to make use of some of
    your ideas!!

  16. Pretty component of content. I just stumbled upon your blog and
    in accession capital to claim that I acquire actually loved
    account your blog posts. Any way I will be subscribing on your feeds and even I fulfillment you get entry to consistently quickly.

  17. Hi I am so glad I found your site, I really found you by accident, while I was browsing on Bing for something else,
    Anyhow I am here now and would just like to say cheers for a fantastic post and a all round exciting blog (I also love the theme/design), I don’t have
    time to go through it all at the minute but I have bookmarked it and also
    added in your RSS feeds, so when I have time I will be back to read a lot more, Please
    do keep up the superb work.

  18. Hurrah! Finally I got a weblog from where I be capable of really obtain helpful facts regarding my study and
    knowledge.

  19. Your style is very unique compared to other folks I have
    read stuff from. I appreciate you for posting when you
    have the opportunity, Guess I will just book mark this web site.

  20. It’s a shame you don’t have a donate button! I’d most certainly donate to this fantastic blog!
    I guess for now i’ll settle for book-marking and
    adding your RSS feed to my Google account. I look forward to brand new updates
    and will share this blog with my Facebook group.
    Chat soon!

  21. I know this if off topic but I’m looking into starting my own blog
    and was curious what all is needed to get setup? I’m assuming having
    a blog like yours would cost a pretty penny? I’m not very internet smart
    so I’m not 100% sure. Any tips or advice would be greatly appreciated.
    Cheers

  22. After I originally commented I appear to have clicked the -Notify me when new comments are added- checkbox and from now on each time
    a comment is added I receive 4 emails with the exact
    same comment. There has to be a way you can remove me from that service?
    Thanks!

  23. Wow, this article is good, my sister is analyzing these things,
    so I am going to let know her.

  24. Wow, this article is nice, my younger sister is
    analyzing these things, thus I am going to tell her.

  25. I know this web page gives quality depending content and
    extra information, is there any other site which gives such things in quality?

  26. First of all I would like to say superb blog!
    I had a quick question which I’d like to ask if you don’t mind.
    I was curious to find out how you center yourself and clear your
    head before writing. I’ve had a difficult time
    clearing my mind in getting my thoughts out there. I do enjoy writing however it just seems like the first 10 to 15 minutes are usually wasted just trying to figure
    out how to begin. Any recommendations or tips? Thanks!

  27. Having read this I believed it was extremely informative. I
    appreciate you taking the time and effort to put this informative
    article together. I once again find myself personally spending a lot of time both reading and posting comments.
    But so what, it was still worth it!

  28. What i don’t understood is in truth how you’re not really a
    lot more neatly-favored than you might be right now. You’re very intelligent.

    You already know thus significantly in terms of this topic, produced me for my part
    believe it from numerous numerous angles. Its like women and men don’t seem to be interested until it is one thing to do with
    Girl gaga! Your personal stuffs outstanding. At all times
    handle it up!

  29. Hi! Do you know if they make any plugins to protect against hackers?

    I’m kinda paranoid about losing everything I’ve worked hard on. Any suggestions?

  30. It’s going to be end of mine day, except before end I am reading
    this wonderful post to improve my experience.

  31. It is appropriate time to make a few plans for the longer term and it’s time to be happy.
    I’ve learn this put up and if I may just I desire to recommend you some interesting things or tips.
    Maybe you could write subsequent articles referring to this article.
    I desire to read more things about it!

  32. Nice post. I learn something totally new and challenging on blogs I
    stumbleupon on a daily basis. It’s always exciting to read
    through articles from other writers and use something from other websites.

  33. Superb post however , I was wanting to know if you could write
    a litte more on this topic? I’d be very grateful
    if you could elaborate a little bit further. Cheers!

  34. hi!,I really like your writing very a lot! proportion we communicate more approximately your post on AOL?
    I require a specialist on this house to solve my problem.
    Maybe that’s you! Having a look ahead to see you.

  35. Yes! Finally someone writes about Sex Dating.

  36. Usually I don’t read article on blogs, but I would like to say that this write-up very
    forced me to try and do it! Your writing taste has been amazed me.
    Thank you, very nice article.

  37. Hi, its fastidious paragraph on the topic
    of media print, we all understand media is a fantastic
    source of information.

  38. Hi there, just wanted to say, I enjoyed this blog post.
    It was helpful. Keep on posting!

  39. It’s a shame you don’t have a donate button! I’d certainly donate to
    this excellent blog! I suppose for now i’ll settle for bookmarking and adding your RSS feed to my Google account.
    I look forward to brand new updates and will talk about this site
    with my Facebook group. Talk soon!

  40. I all the time emailed this blog post page to
    all my associates, since if like to read it after that
    my links will too.

  41. Wow that was odd. I just wrote an really long comment but after I
    clicked submit my comment didn’t show up. Grrrr… well I’m not writing all
    that over again. Regardless, just wanted to say superb blog!

  42. I am not sure where you’re getting your info, but great topic.
    I needs to spend some time learning much more or understanding more.

    Thanks for fantastic info I was looking for this info
    for my mission.

  43. Hello, i believe that i noticed you visited my web site so i came to return the choose?.I am attempting to to
    find things to improve my website!I assume its
    adequate to make use of a few of your ideas!!

  44. Hello, i feel that i noticed you visited my blog so i got
    here to return the choose?.I am trying to find things to
    enhance my site!I assume its good enough to use a few of your ideas!!

  45. This website really has all the information I wanted concerning this
    subject and didn’t know who to ask.

  46. Thanks for finally talking about > 【医療機器企業リスクマネジメント】ISO
    14971:2019逐条解説 | お役立ち情報 < Liked it!

  47. Hey there! I’ve been reading your website for some time
    now and finally got the courage to go ahead and give you a
    shout out from Atascocita Texas! Just wanted to say keep up
    the excellent job!

  48. Attractive section of content. I just stumbled upon your weblog and in accession capital to assert that I acquire
    in fact enjoyed account your blog posts. Any way I’ll be subscribing
    to your feeds and even I achievement you access consistently quickly.

  49. I’m not sure exactly why but this website is loading extremely
    slow for me. Is anyone else having this issue
    or is it a issue on my end? I’ll check back later and see if the problem still exists.

  50. I’ve been absent for a while, but now I remember why I used to love this blog. Thanks, I will try and check back more often. How frequently you update your site?

  51. I have to point out my gratitude for your kind-heartedness supporting those people that absolutely need help with this particular area of interest. Your special commitment to getting the solution around ended up being really important and has continuously empowered others like me to achieve their aims. Your new informative instruction denotes so much a person like me and additionally to my office workers. Regards; from all of us.

  52. Hello my family member! I wish to say that this article is awesome, nice written and come with almost all significant infos. I would like to look extra posts like this.

  53. Some times its a pain in the ass to read what people wrote but this site is rattling user genial! .

  54. Thanks for the sensible critique. Me and my neighbor were just preparing to do a little research on this. We got a grab a book from our local library but I think I learned more clear from this post. I am very glad to see such excellent info being shared freely out there.

  55. Good day very nice blog!! Guy .. Excellent .. Amazing .. I’ll bookmark your web site and take the feeds also…I am satisfied to seek out so many helpful information right here in the post, we need work out extra techniques on this regard, thanks for sharing.

  56. I do agree with all of the ideas you’ve presented in your post. They’re very convincing and will definitely work. Still, the posts are very short for starters. Could you please extend them a little from next time? Thanks for the post.

  57. This web page is mostly a walk-by way of for all the data you needed about this and didn’t know who to ask. Glimpse right here, and you’ll positively discover it.

  58. What Is Puravive? Before we delve into the various facets of the supplement, let’s start with the most important

  59. I’m really enjoying the design and layout of your blog. It’s a very easy on the eyes which makes it much more enjoyable for me to come here and visit more often. Did you hire out a developer to create your theme? Excellent work!

  60. I am glad that I detected this weblog, exactly the right info that I was looking for! .

  61. Please let me know if you’re looking for a article author for your weblog. You have some really great posts and I think I would be a good asset. If you ever want to take some of the load off, I’d really like to write some articles for your blog in exchange for a link back to mine. Please send me an e-mail if interested. Thanks!

  62. I was very pleased to find this web-site.I wanted to thanks for your time for this wonderful read!! I definitely enjoying every little bit of it and I have you bookmarked to check out new stuff you blog post.

  63. Java Burn: What is it? Java Burn is marketed as a natural weight loss product that can increase the speed and efficiency of a person’s natural metabolism, thereby supporting their weight loss efforts

  64. fantastic issues altogether, you simply gained a logo new reader. What might you suggest in regards to your put up that you simply made a few days ago? Any sure?

  65. You really make it appear so easy together with your presentation but I in finding this topic to be really one thing which I feel I would never understand. It sort of feels too complex and very vast for me. I am having a look ahead in your subsequent put up, I will try to get the dangle of it!

  66. I reckon something truly interesting about your web site so I saved to fav.

  67. I haven?¦t checked in here for a while since I thought it was getting boring, but the last several posts are great quality so I guess I?¦ll add you back to my daily bloglist. You deserve it my friend 🙂

  68. I have been exploring for a bit for any high quality articles or blog posts on this sort of area . Exploring in Yahoo I at last stumbled upon this web site. Reading this information So i’m happy to convey that I’ve a very good uncanny feeling I discovered just what I needed. I most certainly will make certain to don’t forget this web site and give it a look regularly.

  69. I have been surfing on-line more than three hours lately, yet I by no means discovered any interesting article like yours. It is beautiful value sufficient for me. In my opinion, if all site owners and bloggers made excellent content as you probably did, the net will likely be a lot more helpful than ever before.

    • Cherilyn Butscher
    • 2024.05.27

    Great website. Plenty of useful information here. I’m sending it to some friends ans also sharing in delicious. And naturally, thank you on your sweat!

  70. you’re in reality a excellent webmaster. The site loading velocity is incredible. It seems that you are doing any distinctive trick. Also, The contents are masterpiece. you have done a excellent activity in this matter!

  71. Hey, you used to write wonderful, but the last several posts have been kinda boring… I miss your tremendous writings. Past few posts are just a bit out of track! come on!

  72. You actually make it seem so easy with your presentation but I find this topic to be really something which I think I would never understand. It seems too complex and extremely broad for me. I’m looking forward for your next post, I will try to get the hang of it!

  73. Thank you, I’ve just been looking for info about this topic for ages and yours is the greatest I have discovered till now. But, what about the bottom line? Are you sure about the source?

  74. hey there and thank you for your info – I have certainly picked up something new from right here. I did however expertise a few technical points using this web site, since I experienced to reload the web site lots of times previous to I could get it to load correctly. I had been wondering if your hosting is OK? Not that I’m complaining, but slow loading instances times will often affect your placement in google and can damage your quality score if ads and marketing with Adwords. Anyway I am adding this RSS to my e-mail and can look out for a lot more of your respective interesting content. Ensure that you update this again soon..

  75. It’s remarkable designed for me to have a site,
    which is valuable for my knowledge. thanks admin

  76. Nice read, I just passed this onto a colleague who was doing a little research on that. And he just bought me lunch because I found it for him smile So let me rephrase that: Thank you for lunch! “By nature, men are nearly alike by practice, they get to be wide apart.” by Confucius.

  77. Some genuinely nice and utilitarian info on this website, too I believe the layout holds superb features.

  78. A person essentially help to make seriously articles I would state. This is the first time I frequented your web page and thus far? I surprised with the research you made to make this particular publish amazing. Fantastic job!

  79. I haven’t checked in here for some time since I thought it was getting boring, but the last several posts are good quality so I guess I’ll add you back to my daily bloglist. You deserve it my friend 🙂

  80. One such software that has been generating buzz these days is the Lottery Defeater

  81. Needed to post you this bit of note so as to thank you very much yet again for these precious techniques you have shared on this site. This has been certainly remarkably open-handed of you to present publicly what exactly a lot of people might have advertised as an electronic book to help make some dough for themselves, certainly considering that you might have tried it if you ever decided. Those thoughts in addition worked as the fantastic way to be certain that other individuals have the identical passion just like mine to know very much more with respect to this condition. I think there are millions of more pleasant occasions up front for many who view your blog post.

  82. certainly like your web site but you have to test the spelling on several of your posts. Several of them are rife with spelling problems and I find it very bothersome to tell the reality however I will surely come again again.

  83. A lot of thanks for all your valuable labor on this site. Kate really loves conducting investigations and it’s easy to see why. A number of us learn all relating to the powerful way you present efficient tactics on the website and as well as encourage contribution from some others about this topic plus our favorite girl has always been studying a lot. Enjoy the remaining portion of the year. You are doing a remarkable job.

  84. Thanks for this terrific post, I am glad I discovered this internet site on yahoo.

TOP