The ISO 13485 standard is being revised and the new version will be released early in 2016. It was originally expected to be released in the fall of 2015 along with the updated ISO 9001 standard, but there were 800 comments on the DIS2 draft and a final version was submitted for voting in October. Below is the link for my article describing the changes:

http://www.bonezonepub.com/component/content/article/1198-big-changes-in-iso-134852015

One of the changes is to the management review process. The new process requires that you justify the frequency for your management reviews and document this justification. It also requires that you document your plan to address new and revised changes to regulatory requirements as an output of your management review meetings. My recommendation is to start planning the changes to your QMS starting in January with your first management review of the year.

Here’s my suggested preparation plan:
1. schedule your next management review for late January or early February 2016
2. update your management review procedure for the proposed changes
3. download a copy of my free management review webinar:

http://medicaldeviceacademy.com/management-review-webinar/

4. retrain top management on the new procedure and ask them to watch the webinar
5. download a copy of my free quality plan template:

http://medicaldeviceacademy.com/quality-system-plan-template/ – form at the end of page

6. assign each member of top management one of the items in the plan to be responsible for as process owner (some might be responsible for more than one)
7. ask each member of top management to send you one slide explaining their plan for revisions to the QMS to address changes to ISO 13485 in their area of responsibility
8. ask each member of top management to propose a revised quality objective related to their area of responsibility; quality objectives should be related to risk-based controls of their process and should be part of your monitoring and measurement of processes
9. sign-up for my new webinar on “Planning Your 2016 Audit Schedule” (only $129)

http://medicaldeviceacademy.com/planning-2016-annual-audit-schedule/

10. propose an updated internal audit schedule for 2016 during your January management review meeting, based upon what you learn in the webinar

I’m sure many of you are already planning your next management review meeting and you are involved in strategic business planning for 2016. Here’s two more things to keep on your radar screen for 2016:
1. EU regulations are expected to be released as a draft in April by the Dutch Presidency
2. EMC testing to IEC 610101-1-2, 4th edition transition deadline is August 1, 2016 for US FDA submissions of electronic devices

http://www.eisnersafety.com/iec-60601-1-22014-4th-ed-what-is-the-impact-of-this-puzzle-on-your-product-design/

I also have three holiday wishes you can help me with:
1. Please invite a friend to join our LinkedIn Group
2. Please subscribe to my blog: http://medicaldeviceacademy.com/blog/
3. Please submit your ideas for future announcements, blogs and webinars to my updated suggestion box:

http://medicaldeviceacademy.com/suggestion-box/

If you are located in Europe, hopefully I’ll see you at my CE Marking and 510(k) workshop on February 9, 2016 at University of Oxford ($799/person):

http://medicaldeviceacademy.com/ce-marking-workshop-and-510k-submissions-workshop/

source: https://www.linkedin.com/groups/2070960/2070960-6082944075940577285