R&Q's Blog

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

 

What does Brexit mean to your medical device company?

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The UK Parliament has rejected Prime Minister Theresa May’s Brexit plan (January 15, 2019). This does not make predicting the future easier. It is possible that the government will come back with a new plan, or, there will be a no-deal Brexit. In the case of a no-deal Brexit, the EU will not accept UK Notified Body certificates or recognize UK-based authorized representatives, which puts a strain on companies trying to sell into the EU.

Our Advanced EU MDR and CER Workshop is coming to California in December at DeviceTalks West

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Note: Presenters/Panelists listed below subject to change.

R&Q is bringing our Advanced EU MDR and CER Workshop to DeviceTalks West! Join us Dec.12 for an extensive, detailed look at EU MDR and CERs through the lens of top industry experts who have successfully implemented large-scale EU MDR programs and completed 100’s of CERs. These experts have seen what works and what doesn't, and will be sharing tips, tricks, and lessons learned.

What's more, if you'd only like to attend the workshop and not the entire conference, we've made that possible. Here are the registration codes:

RQFULL - 50% full conference pass
RQWORKSHOP - $75 for workshop only (also includes networking opportunities)

At a small company and think this doesn't apply yet? This may not be on your radar, but it should be. You'll learn from the successes and failures of larger companies who are several months into the transition, and acquire the knowledge to nimbly navigate the transition efficiently. If your organization has many device changes planned, it’s crucial to get started in order to complete the transition by May 2020.

Read on for a closer look at the workshop and an exclusive registration discount code for DeviceTalks Boston.

New webinars, major events... hello, fall!

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First thing's first: our free webinars are back.

Over the next three months – beginning September 25 – we'll be covering combination products, EU MDR, and economic operators. Slides, recordings, and Q&A will be made available to everyone who registers.

We've made it easy for you to sign up once and get on the list for all three webinars below. Why sign up? Because our industry-leading experts are sharing lessons learned from experiences they've lived through. We present the most important information and compile critical takeaways we believe you can implement right away.

 

Yes! Sign up for 3.

 

R&Q Q&A: Employee Spotlight and Career Opportunities

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This is our R&Q Q&A series. Every few months we ask R&Q employees how they make their impact at R&Q... and the impact R&Q has had on them. From improving people's lives to R&Q's rewarding culture, we hope their answers shed light on how our company influences the medical device industry and why our employees claim time and time again working at R&Q is a highly fulfilling experience. View all R&Q openings on our Careers page.

Not your average EU MDR and CER workshop

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Note: Presenters/Panelists listed below subject to change.

DeviceTalks Boston is Oct. 8-10 this year and as part of it, R&Q is helping to organize an Advanced EU MDR and CER Workshop. It's an extensive, detailed look at EU MDR and CERs through the lens of top industry experts who have successfully implemented large-scale EU MDR programs and completed 100’s of CERs. They've seen what works... and what doesn't, and will be sharing tips, tricks, and lessons learned.

At a small company and think this doesn't apply yet? This may not be on your radar, but it should be. You'll learn from the successes and failures of larger companies who are several months into the transition, and acquire the knowledge to nimbly navigate the transition efficiently. If your organization has many device changes planned, it’s crucial to get started in order to complete the transition by May 2020.

Read on for a closer look at the workshop and an exclusive registration discount code for DeviceTalks Boston.

Taking it up a notch at DeviceTalks Minnesota

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DeviceTalks Minnesota is right around the corner and we couldn't possibly be more excited - really. June 4-5 is only a little over three weeks away! We've witnessed the growth of this event first-hand over the past few years and this year we're confident will be the best yet, especially considering the new partnership with the Medical Alley Association (MAA). R&Q sees this as the premier medtech event in Minnesota in 2018, which is why we've decided to be a Platinum Sponsor this year. Beyond that and most importantly, we're helping to craft the educational content of the Regulatory 2.0 track, presented by MAA. 

🔑 Unlock the Secrets to CERs in our May Webinar

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Unlock the secrets to complying with the increased requirements for CERs in May's free R&Q webinar:

 

CERs – Tips, Tricks, and Lessons Learned

 

Sign Up

 

The session will be on Tuesday, May 22 from 1:00pm - 2:00pm EST. The presentation slides, webinar recording, and Q&A will be made available to registrants - whether you can attend the live presentation or not.

 

Webinar details

You have heard about the increased requirements for clinical evaluation with MEDDEV 2.7/1 Rev 4 and the MDR. You may be working on new templates and updating your CERs.

 

And now come the questions...

  • What do these requirements really mean?
  • Why are we doing this?
  • How are we going to get this all done?

 

💼 EU MDR – Proactive Post-Market Surveillance [Upcoming Webinar]

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It's time for our next free R&Q Intelligence Series webinar.

The sessionEU MDR – Proactive Post-Market Surveillance: The requirements and staff it will take to do it. – will be held Tuesday, April 24ᵗʰ from 1:00pm - 2:00pm EST. If you can't view the webinar live, we encourage you to register anyway, as the presentation slides, webinar recording, and Q&A will be shared with all registrants.

Click below to sign up and read on for more details about the webinar. We hope you can join us!

 

Sign Up

R&Q Q&A: Employee Spotlight and Career Opportunities

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Welcome back to our R&Q Q&A series. Every few months we ask R&Q employees how they make their impact at R&Q... and the impact R&Q has had on them. From improving people's lives to R&Q's rewarding culture, we hope their answers shed light on how R&Q influences the medical device industry and why our employees claim time and time again working at R&Q is a highly fulfilling experience. View all R&Q openings on our Careers page.

📚 Technical Documentation for EU MDR [Upcoming Webinar]

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Our monthly R&Q Intelligence Series webinar is right around the corner and we want to be sure you know about it.

The free sessionTechnical Documentation for EU MDR: How much remediation will you need to do? – will be held Tuesday, February 27ᵗʰ from 1:00pm - 2:00pm EST. If you can't experience the webinar live, we encourage you to register anyway, as we share the presentation slides, webinar recording, and Q&A with registrants.

Click below to sign up and read on for more details about the webinar. We hope you can join us!

 

Sign Up

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