R&Q's Blog

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

 

🔑 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

 

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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!

 

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📚 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!

 

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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?”

Preparing your CER for MDR [Upcoming Webinar]

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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!

Webinar Q&A: EU MDR / CER Portfolio Planning

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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 requirementsPortfolio 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.

EU MDR / CER Portfolio Planning: The Essential Requirements [Free Webinar]

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What? 

Please join us for September's free R&Q Intelligence Series webinar:
EU MDR / CER Portfolio Planning: Know the essential EU MDR portfolio planning requirements.

The session will take place Tuesday, September 26 from 1:00pm - 2:00pm EST.

 

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.

The time to plan is now.

MEDDEV 2.7/1 & CERs: Questions and Answers

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Clinical evaluation requirements have been changing, with the latest impact coming from MEDDEV 2.7/1 Rev 4. Preparing for and meeting these requirements is important because the grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision.

Furthermore and once the regulation comes into force, the European Medical Devices Regulation (MDR) will impact CERs as well. It is important to be proactive to ensure CERs will meet your notified body expectations. You must review your clinical strategy carefully.

R&Q recently presented the webinar, MEDDEV 2.7/1 & CERs: Know the changes and what to do. Towards the end of the session we answered several questions, a sample of which are below. To see all questions and answers from the session - along with the slides and recording - check out the on-demand webinar.

Cybersecurity for Medical Devices: Questions and Answers

As the number of network connected medical devices increases, opportunities for improved patient care also increase. As a consequence, the vulnerability to cyber-attacks becomes a greater threat. Medical device cybersecurity threats can be dangerous for providers, networks, and device manufacturers. They can put patient safety at risk and/or create a breach of data. The FDA encourages manufacturers to consider potential cybersecurity risks and vulnerabilities “throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device.”

R&Q recently presented the webinar, Cybersecurity: Regulatory and quality ramifications. During the session we answered several of your questions, a sample of which are below. To see all of the questions and answers from the session, along with the slides and recording, check out the on-demand webinar.

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