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 complying with the increased requirements for CERs in May's free R&Q webinar:
CERs – Tips, Tricks, and Lessons Learned
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?
It's time for our next free R&Q Intelligence Series webinar.
The session – EU 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!
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.
Our monthly R&Q Intelligence Series webinar is right around the corner and we want to be sure you know about it.
The free session – Technical 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!
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.
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?”
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 for 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.
R&Q's next Intelligence Series webinar, Preparing your CER for MDR: Gathering Clinical Evidence, will be held on Tuesday, Novemer 28th from 1:00pm - 2:00pm EST. The presentation slides, webinar recording, and Q&A will be made available to registrants.
Register in seconds at the link below, and read on for full webinar details. We hope you'll join us!
ISO has published a companion handbook to ISO 13485:2016, Medical devices-Quality management systems - Requirements for regulatory purposes. From AAMI:
It provides users with practical guidance and accurate interpretation of the requirements specified in the standard. It offers device manufacturers step-by-step guidance applicable to the all stages of a medical device's life cycle from gathering customer requirements to design and through to post-market surveillance of devices. This go-to resource is ideal for regulatory, compliance, quality management professionals who are committed to implementing and maintaining a quality management system that is effective and meets applicable regulatory requirements.
In September and as part of the R&Q Intelligence Series, we conducted the webinar, EU MDR / CER Portfolio Planning: Know the essential EU MDR portfolio planning requirements. Portfolio planning is a key aspect of interfacing with your notified body. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’ schedules.
At the conclusion of the webinar we answered several questions, and a sampling of those questions and answers is below. To read more about the webinar, read all questions and answers from the session, and gain access to the slides and recording, check out the on-demand webinar.
