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?


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.

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?”

ISO 13485:2016 Companion Handbook Now Available


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.

NEWS: Bill Introduced to Improve FDA's Medical Device Inspection Process

Senator Johnny Isakson [R-GA]

Note: This post is written by Jake O'Donnell, Senior FDA Compliance Principal at R&Q. Jake has more than 20 years of experience working for the FDA. We hope his commentary brings a useful perspective to the new bill.

Anytime there is an administration change in the federal government, thoughts turn to potential changes in the regulatory environment. With a Republican chief executive and majorities in the 115th Congress, this year is no exception. On February 15th, Senator Johnny Isakson [R-GA] introduced S.404: a bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.

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.

What You Should Do About the Two New FDA Draft Guidance Documents


It has been a long journey for the FDA to get the new draft guidances published on when to submit a 510(k) for a change to an existing device, and another specific to software changes. But on August 8th, it finally happened! For those of you who remember the FDA's attempt at updating the 1997 Memorandum in 2011, that draft guidance was met with general industry pushback, congressional input, an FDA report to congress, and now a new draft guidance.

Wearables are Exploding (Not Literally!) and Transforming the Medical Device Industry

Image via Verily

Smart wearables are turning into a largely profitable industry. From glucose monitoring, to sleep technology, to fitness apps, the number of wearable medical devices on the market are continuing to grow and in turn, help the lives of people - with or without ailments. Many of these devices are meant to ease daily life and prevent invasive and potentially harmful procedures for patients all over the world. This technology also encourages wearers to be actively involved in bettering their own health behaviors.

These innovative devices typically fall into the three categories below.

Announcing R&Q's Newest Senior FDA Compliance Principal: Former FDA Consumer Safety Officer Jake O'Donnell

R&Q is thrilled to announce the newest member of our team. Jake O'Donnell will act as Senior FDA Compliance Principal beginning February 2016. Jake formerly acted as Consumer Safety Officer (CSO) at the FDA for 20 years.

Welcome To R&Q's New Website!

Welcome to R&Q's updated website! To state it plainly, we've revamped our website to better serve the needs of regulatory and quality professionals in the medical device industry. We hope you find it easy to use. Some changes include more clearly outlined services, additional detail on the white papers we offer, and a video that tells the story about how we help our clients, as seen below. You'll notice that the video is the first call-to-action on our homepage, just under, "We help get medical devices to market faster. And keep them there."

United States v. Caronia

Yesterday, the United States Court of Appeals for the Second Circuit (based in NYC) made a 2-to-1 decision on United States v. Caronia (just one of many criminal cases pertaining to off-label use). This case even contained a supplemental briefing that had the litigants brief the applicability of Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), to the Caronia case. In Sorrell, the Supreme Court ruled that a Vermont statute, which regulated certain speaker and content-based restrictions related to pharmaceutical companies was in violation the First Amendment of the U.S. Constitution.

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