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RQM+ Medical Device and In Vitro Diagnostic Blog
Topic: Quality System
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Enhancing Competitiveness in MedTech: Smart Strategies with Regulatory Intelligence
on 6 February 2024 | By Ed Ball, CEng, MIPEM, MIMMM – Manager, Intelligence & Strategic Execution
What is regulatory intelligence? Ok, so what on earth are we talking about when we say regulatory intelligence? There are no formal definitions for regulatory intelligence in regulations or standards relating to medical devices or in vitro diagnostic devices. Without delving...
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Impact of FDA Adoption of ISO 13485
on 7 June 2022 | By Kevin Go, Project Engineer and Nancy Morrison, Executive Director Regulatory and Quality Consulting Services
The FDA’s proposed rule to align its quality system regulation with ISO 13485 has the industry buzzing. What does it mean for medical device and IVD manufacturers? Let’s take a closer look at the proposed changes and what they might mean for manufacturers if they are adopted.
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5 Reasons Not to Fear a Supplier Audit
on 30 August 2016 | By Michelle Mahoney
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,...
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Free Webinar: CAPA on CAPA, Presented by MassMEDIC and R&Q - Register Now!
on 16 August 2016 | By Stephen Biernacki
CAPA is often overlooked as an integral component of a quality system. More often than not, the FDA can trace deficiencies in a system directly back to the CAPA system. However, an effective quality system needs more than just a rework of the outcome of the ineffective CAPA...
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Quality Management | Medical Device Companies | Corporate Quality | Management Reviews | Quality System | Quality Manager | Corporate Policy | Manufacturing Process | Executive Management Team | Quality Policy
Quality Systems Becoming the Culture of a Company
on 18 April 2013 | By Ryan Kasun
The culture of a company is what drives the organization – it can change and adapt, but ultimately, if a strong management team doesn’t drive a company’s culture – the company risks losing its identity. For medical device companies, establishing a culture around the Quality...
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Best Practices | Quality System | Autonomy | Guidance Document | Innovation | Regulatory | Improvements | Quality
Autonomy with Boundaries
on 4 March 2013 | By Ryan Kasun
I have a teenager that just passed his Driver’s Test. As he pulls out of our driveway, I see the freedom, the possibilities, the trouble that he could get into. Although a bit poetic and a bit melancholy, it’s also a bit exciting. His father and I cautiously trust him – he’s a...
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Some Things Never Change....
on 23 January 2013 | By Ryan Kasun
There are some things in life that never change. So, if they never change, let’s learn the rules. A teacher once told me “once you know the rules, embrace them.”
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