R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

ISO 13485:2016 Companion Handbook Now Available

ISO has published a companion handbook to ISO 13485:2016, Medical devices-Quality management systems - Requirements for regulatory purposes. From AAMI:

It provides users with practical guidance and accurate interpretation of the requirements specified in the standard. It offers device manufacturers step-by-step guidance applicable to the all stages of a medical device's life cycle from gathering customer requirements to design and through to post-market surveillance of devices. This go-to resource is ideal for regulatory, compliance, quality management professionals who are committed to implementing and maintaining a quality management system that is effective and meets applicable regulatory requirements.

Webinar Q&A: Risk-Based Approach to ISO 13485:2016

Last month and as part of the R&Q Intelligence Series we conducted the webinar, Risk-Based Approach to ISO 13485:2016: Risk considerations and implementation. Risk considerations and implementation of a risk-based approach in your QMS processes is one of the most significant changes to the current version of ISO 13485. Medical device organizations must define how they manage risk in their processes and how the risk of one process affects other risk aspects of the QMS.

At the end of the webinar we answered several questions, and a sampling of those questions and answers is below. To read more about the webinar, read all questions and answers from the session, and gain access to the slides and recording, check out the on-demand webinar.

A Risk-Based Approach to Your QMS Implementation - ISO 13485:2016 and ISO 9001:2015 [Webinar]

Part of your month, every month: R&Q Intelligence Series webinars are held on the fourth Tuesday of every month. These free webinars from some of the medical device industry's leading-most experts are designed for reporting on and analyzing the top industry trends and topics in the medical device space, each providing key and actionable takeaways for attendees. Slides and recordings will be made available to all registrants. Next up: March 28th, where we'll discuss the Medical Device Single Audit Program (MDSAP).

Vital To-Do for 2017: Prepare for ISO 13485:2016

“Procrastination is the bad habit of putting of until the day after tomorrow what should have been done the day before yesterday.” - Napolean Hill

It's really never too early, especially when it comes to renewing the certifications you need to keep your product on the market. In fact, the time is now to start your transition to ISO 13485:2016. Certification bodies will have difficulty having enough auditors and long wait times are expected. Don’t get caught in that last minute rush to renew certifications.

R&Q’s QMS expert, Mark Swanson, was a member of the ISO working group that revised ISO 13485, so R&Q can bring you detailed information on the intent behind the requirements. R&Q on the whole will ensure you can fully prepare for your certification audit with minimal issues, keeping your product on markets worldwide.

5 Reasons Not to Fear a Supplier Audit

The following post is written by R&Q Senior Engineer, Michelle Mahoney.


One of the toughest things to experience when walking in to audit a company is the tension, anxiety, and fear emanating from those in the room. Taking a look around the room, I notice heads are turned away, eyes are up counting the ceiling tiles, and no one will even make eye contact with me. I already felt like an outsider walking into this company alone, but now I feel it even more so. I realize it's up to me to break the ice and try to settle the nerves of everyone in the room.

"So how 'bout them Red Sox?"

Ok, there's a smile. A chuckle. Some eye contact. Success!

...alright, so that only works when I’m in New England... but you get the idea. 

It's really up to me, as the auditor, to set the mood of the audit within the first few minutes of walking through the door. As much as I hope that the company will be comfortable and relaxed with hosting an audit, there are almost always nerves and anxiety running wild.

One potential reason? The auditees feel the pressure to have a successful audit because if they don't, top management might have a word or two about it. But what the auditees need to realize is that there is nothing to be scared of, and here's why.

A QMS Outcast: Preventive Action

We in the medical device industry throw the term CAPA around like it's a word that is common-place in our society (though, here in Pittsburgh, you'll get a lot of confused looks if you tell someone you've opened a CAPA as it is a local performing arts school. That's a strange nightmare with future Broadway stars re-enacting a root cause analysis!).

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