ISO 13485:2016

When it comes to ISO 13485:2016, are you scrambling to meet requirements?

Are you trying to figure out the how, what, or when regarding its timeline? Or, maybe you just don’t know what you need to do. You are not alone because a lot of companies are behind.

Don’t wait until it is too late. Now is the time to take action.

Today’s guest is Kyle Rose, president of Rook Quality Systems, which helps companies achieve 13485 certification by using the Greenlight Guru’s Quality Management Software platform. Kyle shares some tips and tricks for dealing with 13485 because time is ticking!



Like this episode? Subscribe today on iTunes or SoundCloud.


Some of the highlights of the show include:

● The February 2019 deadline is approaching for most auditing organizations. If you have your audit scheduled before then, it has to be to the new standard.

● If you don’t have your new ISO 2016 certificate by February 2019, you risk losing your ISO certification and other items.

● Create a gap analysis or internal audit plan to review your current QMS and highlight what is missing for the new standard.

● Companies should perform quarterly management reviews. There is a growing expectation that executive management knows the effectiveness of their QMS.

● An element regarding QMS software validation has found its way into the new standard. Refer to Section 4.1.6.

● How do Dropbox, Google Drive, and others play into QMS software validation? Assess, evaluate, and keep a paper copy on hand.

● If you are using software packages or working with a company, that becomes a supplier. Have written agreements that describe the supplier’s role in the QMS.

● Even if you are working with a contract manufacturer that is certified, you still need a QMS and be responsible for your product.



Rook Quality Systems

● Kyle Rose’s email

● Greenlight Guru’s eQMS

● Greenlight Guru Grow Platform

Canada’s Medical Device Single Audit Program

ISO 13485:2016


Quotes by Jon Speer and Kyle Rose:

If you haven’t started the process, it’s already too late.” -Kyle Rose

Your ISO auditor is going to want to see your gap analysis. That is going to be a key artifact as part of this transition process.” -Jon Speer

Our goal is to make it as simple and efficient as possible. If you stick with the standard, you improve your company and your product.” -Kyle Rose



The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Like this episode? Subscribe today on iTunes or SoundCloud.