R&Q's Blog

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

 

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.

Minnesota Momentum: R&Q Hires Member of ISO Technical Committee 210, Mark Swanson

Mark Swanson is R&Q's new Director of Minneapolis–Saint Paul (MSP) Territory. Welcome, Mark!

Mark's addition firmly establishes R&Q in the Twin Cities and prepares R&Q to handle growth in the region. The hiring also builds upon R&Q's existing technical leadership, increasing company-wide capability. Mark will certainly be seen and heard across Minnesota on behalf of R&Q, starting today at MD&M Minneapolis!

Mark is a Senior Member of ASQ and holds ASQ certifications as a Certified Biomedical Auditor (CBA), Certified Quality Engineer (CQE) and Certified Manager of Quality/Organizational Excellence (CMQ/OE).

Read on as we ask Mark three questions about his work on the ISO Technical Committee and shed light on his background/experience.

10 Tips for Adopting the Updated ISO 13485:2016 Standards: Webinar Slides and Recording

Missed our latest webinar on this year's ISO 13485 changes? Now you can download the slides and recording.

R&Q's Director of Regulatory Affairs Nancy Morrison and Client Solutions Advisor Christine Santagate walked through 10 tips for adopting the latest changes. From conducting a gap assessment and creating a quality plan to modifying procedures/processes and auditing, they communicated industry best practices to help those in the industry confidently take the next steps in their process.

The New ISO 13485 Standards are Here! Sign Up for a Free R&Q Webinar

The world's most well known standards for medical device quality management have been updated for the first time since 2003. Released in March by the International Organization for StandardizationISO 13485 provides the universal requirements for manufacturers and service providers to comply to regulatory requirements. The standards aim to establish consistent processes for medical device design, progression, installation and distribution, focusing on the safety of the total life span of the device.

Register Here

Some of the essential changes:

  • Globally aligning regulatory requirements
  • Applying risk management practices throughout the quality managment system
  • Attention to supplier sourcing and selection
  • Supplemental requirements for design activities, such as validation and verfication
  • More specific requirements for Design and Development, Corrective Action and other applications
  • Required Medical Device File to validate compliance to new standards 

The standards must be adopted by 2019, which could prove to be a difficult task for manufacturers. Commencing adoption sooner rather than later will aid a steady transition, and that's why we're hosting a free webinar.

Mergers and Acquisitions: The Devil Is In the Details - A Quality Management System (QMS) Integration Case Study

About R&Q's Case Studies: We hope you enjoy our fourth case study. All of our available case studies can be seen here. Subscribing to our blog is the best way to know when future case studies are available.

 

Challenge

So many companies, so many quality systems.

Medical device companies that are merging with or acquiring companies will often be left with quality systems that have conflicting requirements, or don't align with the parent company's quality system. It's also possible that one of the quality systems may not be compliant with the FDA Quality System Regulation, EU ISO 13485, and others. In R&Q's experience with warning letters and consent decrees, it's often the lack of assessment and alignment of quality systems that results in major discrepancies, often leading to warning letters and if not quickly corrected, consent decrees.

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.

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!).

Making Sense of Standards

You may have heard that last year there were two new releases of EN standards: EN ISO 14971:2012 and EN ISO 13485:2012. What does this mean to you? What are the changes? How much does this affect the way you do business? Compliance to standards can be somewhat overwhelming. After a little digging into the changes to EN ISO 14971 and EN ISO 13485, hopefully I can provide you with a little clarity.

Architect of Quality - Part 1

Have you ever wondered where quality management systems came from, or why these infrastructures are designed the way they are? In an effort to explore our roots at RQS, this post is the first in a series about Joseph M. Juran who was a dominant figure in the development and dissemination of quality related concepts that we use in manufacturing today. His autobiography is entitled Architect of Quality1, and his design influence can be seen in many aspects of current quality systems. Let’s take a look at Mr. Juran’s life and contributions to this field.

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