Search results

Home / Search

Category:
Select
Select

11272 results

Guest

Guest

Create New Topic As guest or Sign in

HTML tags are not allowed

Select

Assign topic to the user

  • Differences between ISO 13485:2003 and ISO 13485:2016

    1. What are the exact differences between ISO 13485:2003, ISO 13485:2016?

    The European standard, EN ISO 13485:2012 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes, has been published, after approval by CEN on January 24, 2012. This replaces EN ISO 13485: 2003, although the text of the global standard ISO 13485:2003 is unchanged, only the foreword and annexes in the European version have been revised. Therefore, there are no different requirements in ISO 13485:2012 compared to ISO 13485:2003. 

    To identify new requirements of ISO 13485:2016 vs 13485:2003, at the end of the new ISO 13485:2016, in Annex A there is a table - Comparison of content between ISO 13485:2003 and ISO 13485:2016, where you can see all new requirements and differentiation between these two versions.  

    On the following link, there is an article with the list of mandatory documents required by ISO 13485:2016: https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/ 

    On the following link you can download free matrix ISO 13485:2016 vs. ISO 13485:2003: https://info.advisera.com/13485academy/free-download/iso-13485-2016-vs-iso-13485-2003-matrix

    Also, you can find on Advisera 13485 blog a lot of articles considering certain requirements from ISO 13485: 2016 and how you can fulfill them: ISO 13485 Blog https://advisera.com/13485academy/blog/

    2. What portions of FDA cGMPS, are being revised to comply with ISO 13485:2016?

    While adherence to ISO 13485 is not explicitly required, FDA 21 CFR Part 820 Quality System Regulations is the law for medical device companies manufacturing and selling products for the U.S. market. there are some differences between FDA 21 CFR Part 820 and ISO 13485. Yet prior to the publishing of ISO 13485:2016, it has been a very common practice for medical device companies to establish a QMS to address both FDA 21 CFR Part 820 and ISO 13485:2003.

    For more information about differences and similarities between FDA 21 CFR Part 820 and ISO 13485, please see the following link:

    • Differences and similarities between FDA 21 CFR Part 820 and ISO 13485 https://advisera.com/13485academy/blog/2017/10/05/differences-and-similarities-between-fda-21-cfr-part-820-and-iso-13485/

    • SAR

      Employees, like other data subjects, have the right to access their personal data. When you receive a SAR (Subject Access Request) you need to reply without undue delay (usually one month) and you can extend such a period to another month for complex requests.

      You need to give access to the employee to data stored excluded for documents subjects to legal privilege (i.e. legal advice on the employee), data concerning third parties, disproportionate request.

      You should also inform the employee about the categories and the purposes of data processing, how data have been processed, the legal ground of processing, the source of data (if data were not communicated by the employee), data retention periods, other data subjects rights, if data had been transferred to third parties, security measures if any automated processing method applies. Usually, all this information is included in the employee privacy policy.

      Please consider that if the SAR is too generic you can ask for clarification to the employee, if the employee is not legitimate to access, you can reply with a denial, but do not ignore the request otherwise the employee can lodge a complaint to the Data Protection Authority of your country.

      Here you can find more information:

      If you want to know more about GDPR compliance you can consider enrolling in this EU GDPR Foundations Course: https://advisera.com/training/eu-gdpr-foundations-course//

    • 15223-1 and 13485 certification question

      Do i need to purchase iso 15223-1 in order to comply with a medical device app?

      Yes, you need to purchase this standard. But please be careful because the new revision of this standard is currently under development: ISO/DIS 15223-1 Medical devices — Symbols to be used with medical device labels, labeling, and information to be supplied — Part 1: General requirements.

      There are some new symbols that are applicable to all medical devices, regarding the type of medical device.   

      Furthermore, can the iso 13485 certification and the CE certification be done by the same organization?

      Yes, both certifications can be done by the same Notify body, moreover, it is recommended and expected. 

      The following article regarding compliance with the MDR requirements for medical device labels can be helpful:

Page 287-vs-13485 of 1128 pages

Didn’t find an answer?

Start a new topic and get direct answers from the Expert Advice Community.

CREATE NEW TOPIC +