R&Q's Blog

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

 

MDSAP: What is it? Is it for me? How will I get it done? [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: April 25th, where we'll discuss EU MDR.

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.

FDA’s Guidance Document on Voluntary Submission of ISO 13485 3rd Party Audit Reports

I came across an FDA guidance document – not entirely recent; however, I found it very interesting and worth sharing. It is on voluntary submissions of audit reports done by auditing bodies outside of the FDA.

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