What Is It?

ISO 13485 is a quality management system that is used internationally. It controls safety in work environments, risk management, and design, and creates requirements for inspections, documents, procedures, and verification of safety and effectiveness of medical devices.

 

There is a pattern presented here, where the updates of these quality management systems generally alternate, and the ISO 13485 updates resemble the latest versions of ISO 9001s. However, although ISO 13485 is similar to the other system, does not mean that it replaces it. A manufacturer would still have to meet the requirements presented in ISO 9001 if they want to follow this system.

 

 

Changes Between ISO 13485 Versions

The most current ISO 13485 version that is used is from 2016. Here is a comparison of the latest revision to the 2012 version:

In this new version, ISO 13485 better covers the requirements needed to export to the U.S. market, which is in 21 CFR part 820, so manufacturers following the ISO should have an easier time expanding. The newer version has also added in a lot more requirements and standards for manufacturers to follow that were not present in previous versions of ISO.

How RegDesk Can Help

It is important to understand quality and safety requirements whether a company intends to distribute products in the U.S. or elsewhere. This shift in the ISO quality requirements will bring in new changes that are important for manufacturers to know about. RegDesk provides medical device companies with all the safety requirements and regulation information required to help them register their devices and distribute them to the market. We track and monitor any ISO changes in order to give our clients the most up-to-date information. RegDesk also provides information for over 100 markets worldwide to help medical device and pharmaceutical companies expand internationally.

 

 

340 Comments

  1. Very neat blog. Really looking forward to read more. Really Great.

    Reply
  2. Heya i am for the first time here. I found this board and I
    find It really useful & it helped me out a lot. I hope to give something back and aid others like you helped
    me.

    Feel free to visit my site arava (arava-drugq.blogspot.com)

    Reply
  3. 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% sure.
    Any tips or advice would be greatly appreciated.
    Kudos

    Feel free to visit my website; adalat medicine

    Reply
  4. Attractive component to content. I just stumbled upon your weblog and in accession capital to claim that I get in fact loved account your
    weblog posts. Anyway I’ll be subscribing on your augment or even I
    fulfillment you get admission to consistently fast.

    My homepage … carslot88 pragmatic

    Reply
  5. Very neat and clean blog this is very useful to me thanks for sharing

    Reply
  6. I’m gone to convey my little brother, that he should also pay
    a quick visit this webpage on regular basis to get updated
    from newest news.

    Feel free to surf to my page daftar slot online [qpxy.net]

    Reply
    • Hello
      Please i just took up macaw breeding as a hobby after my mom passed away because they were her favorite birds. Despite the fact that they are very intelligent, am finding it very difficult getting them to mate.
      For any information CLICK HERE http://supremeparrotfarm.company.com/ we shall get back to you. THANKS

      Reply
  7. Hey there just wanted to give you a brief heads up and let you
    know a few of the pictures aren’t loading properly.
    I’m not sure why but I think its a linking issue. I’ve tried it in two different
    browsers and both show the same outcome.

    Also visit my blog post – daftar slot online

    Reply
  8. Good day! This is kind of off topic but I need some help from an established blog.
    Is it very difficult to set up your own blog?
    I’m not very techincal but I can figure things out pretty fast.
    I’m thinking about creating my own but I’m not sure where to begin.
    Do you have any points or suggestions? Many thanks

    Here is my website … carslot88

    Reply
  9. Oh my goodness! Incredible article dude! Many thanks, However I am experiencing issues with your RSS.
    I don’t understand why I am unable to join it.

    Is there anybody having similar RSS issues?
    Anyone that knows the answer can you kindly respond?
    Thanks!!

    My web page – carslot88

    Reply
  10. Hey there! This post could not be written any better!
    Reading through this post reminds me of my old room mate!
    He always kept chatting about this. I will forward this article to
    him. Pretty sure he will have a good read. Thanks
    for sharing!

    Here is my web site; daftar slot online

    Reply
  11. My brother suggested I might like this web site. He was totally right.
    This post actually made my day. You can not imagine just
    how much time I had spent for this info! Thanks!

    Also visit my blog: carslot88

    Reply
  12. Hello i am kavin, its my first occasion to commenting anywhere, when i read this post i thought i could also create comment due to this good post.

    Check out my web site … daftar slot carslot88

    Reply
  13. Wonderful, what a weblog it is! This webpage gives useful
    data to us, keep it up.

    My website; carslot88

    Reply
  14. I do accept as true with all of the concepts you have presented
    on your post. They are very convincing and will certainly work.
    Still, the posts are very quick for novices. Could you please lengthen them
    a little from next time? Thanks for the post.

    Visit my blog … daftar slot carslot88

    Reply
  15. Currеntly it seems like BlogEngіne is tһe top bⅼogցing platform availaЬle right noԝ.

    (from what I’ve read) Is that what you’re using
    on yoour blog?

    Also viѕit my blog; Rego Check

    Reply
  16. Wonderful ցoods from yоu, man. I’ve understand үour stuff prevіous
    to and yoս аre ϳust extremely fantastic.
    I realⅼy lіke wһat you һave acquired here, certainly lіke wһat yⲟu’re saying and thе
    way in ᴡhich yoᥙ ѕay it. You mɑke it entertaining аnd you stilⅼ care for to keep it wise.

    I ⅽаn’t wait to гead fɑr more from you. This is really a
    wonderful web site.

    Ꭺlso visit my web-site :: slot deposit telkomsel

    Reply
  17. Great site you have got here.. It’s difficult to find excellent writing like yours nowadays.
    I really appreciate people like you! Take care!!

    Also visit my web blog – judi slot online

    Reply
  18. Hello
    Please i just took up macaw breeding as a hobby after my mom passed away because they were her favorite birds. Despite the fact that they are very intelligent, am finding it very difficult getting them to mate.
    For any information CLICK HERE http://supremeparrotfarm.company.com/ we shall get back to you. THANKS

    Reply
  19. Hello
    Please i just took up macaw breeding as a hobby after my mom passed away because they were her favorite birds. Despite the fact that they are very intelligent, am finding it very difficult getting them to mate.
    For any information CLICK HERE QUAKER PARROT FOR SALE.THANKS

    Reply
  20. Excellent article. Keep posting such kind of information on your site.
    Im really impressed by your blog.
    Hi there, You have done an incredible job. I will certainly digg it and
    personally recommend to my friends. I’m sure they’ll be benefited from this site.

    Reply
  21. https://emotietherapeut.nl/easy-lifestyle-changes/#comment-14263 Result: слишком большая страничка, РЅРµ докачано; использован никнейм “RichardGeata”; Grabbed info: “mandrichenko.victorgmail.com”, etc. ; успех (СЃ первой страницы);

    Reply

Submit a Comment

Your email address will not be published. Required fields are marked *