R&Q's Blog

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

 

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

Webinar Q&A: Preparing your CER for MDR

RQ Webinar Preparing Your Clinical Evaluation Report for EU MDR Changes

Note: R&Q's first Intelligence Series webinar of 2018 will be held on January 23rd – QMS for EU MDR: Does your quality system meet the additional requirements? Sign up here!

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Back in November and as part of the R&Q Intelligence Series, we held the webinar, Preparing your CER for MDR: Gathering Clinical Evidence.

The upcoming EU MDR requires enhanced clinical evidence to support the device whether you have Class I or Class III products. For products that have been on the market a long time there may be limited or no clinical studies, and yet, the new European Medical Device Regulations require your organization to provide clinical evidence on all your devices. The time to plan and act on these changes is most certainly now.

At the conclusion of the November webinar we answered many questions (the most of any webinar - so thank you!), and some of those questions and answers are below. To read more about the webinar, read all questions and answers, and gain access to the slides and recording, check out the on-demand webinar.

Welcome, Jacob Foster: Regulatory and Quality Solutions' New Senior Principal Engineer

Jacob Foster brings 20+ years of medical device and pharmaceutical regulatory, quality, and project management experience to R&Q. He also brings an engaging personality, eager to do more for clients.

Pittsburgh, PA -- Regulatory and Quality Solutions LLC (R&Q) exists to improve people’s lives and bring more safe and effective medical devices to market for medical device and combination product companies. Our results derive from a cohesive, hard-working, entrepreneurial, and supportive culture – a culture in which Jacob Foster effortlessly fits in.

R&Q is truly ecstatic to announce that Jacob Foster has been named Senior Principal Engineer.

An industry veteran of the global pharmaceutical and medical device industries, Foster brings extensive management, project leadership, and hands-on quality systems development experience to R&Q’s rapidly expanding operations team. His years of experience in the ever-changing regulatory environment  - including the upcoming and all-important EU MDR - strengthens R&Q's ability to expertly and efficiently serve clients. Foster has lived through uncertain times in the industry and despite the complexity of changes, has a track record of successfully navigating and deciphering them.

“I met the team at R&Q about three years ago, and became “fast friends” with each and every team member I was introduced to," said Foster. "So when the opportunity arose to join R&Q, it was one of the easiest decisions I have ever had to make. The culture of R&Q and the earnest sincerity to contribute to patient safety and client success is tangible. Who would not want to be a part of that?”

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