.svg){kind=icon}
RQM+ Medical Device and In Vitro Diagnostic Blog
Topic: medical device
Sorry, no listings found for that Search. Try changing your fiter and search again.
-
European Union Expert Panel's Review of a Novel Neurostimulation Device
on 21 November 2022 | By Andrew Tarnaris, M.D. MD (Res) FRCS (NeuroSurg), RQM+ Medical Director
A new opinion (CECP-2022-000222) provided under the Clinical Evaluation Consultation Procedure (CECP) was recently published by the European Commission. Here are some things worth noting, a summary to digest and lessons learnt both for manufacturers and notified...
Read More -
FDA CDRH: What will they do in 2022?
on 26 January 2022 | By Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer)
“It’s tough to make predictions, especially about the future.” Whether baseball Hall of Famer-slash-philosopher Yogi Berra actually said these words or not, the sentiment rings true, as anyone who has tried to predict the course of the COVID-19 pandemic would know. Predicting...
Read More -
EU MDR Article 61 and equivalence – is there a new way forward?
on 20 December 2021 | By Amie Smirthwaite BEng, PhD, RQM+ Senior Vice President, Intelligence & Innovation
About this article: Could there be more scope for use of equivalence data under EU MDR than you may have thought? Dr. Amie Smirthwaite, Sr. VP of Global Intelligence & Innovation at RQM+, EU MDR expert, thought leader, and member of the working groups that authored MDCG 2020-5...
Read More -
UK Approved Bodies: on your UKCA mark, get set, go!
on 17 December 2021 | By Edward Ball, CEng MIPEM MIMMM, RQM+ Senior Consultant
The world of medical device regulation has seen immense change in past years. The EU MDR has been at the forefront of every agenda for some time – and the one-year deadline delay provided valuable extra time for businesses to get their act together. That one-year delay also...
Read More -
What do we know so far about post-Brexit medical device regulation?
on 14 December 2021 | By Edward Ball, CEng MIPEM MIMMM, RQM+ Senior Consultant
What do we know so far about post-Brexit medical device regulation? With the new European MDR and IVDR regulations at the forefront of every conversation across the medical device industry, the emerging UK regime may have been overlooked as another pending compliance challenge....
Read More -
Canada Regulations News for Medical Devices and IVDs
on 3 December 2021 | By Nancy Morrison, RQM+
In case you missed it, the Medical Device Regulations in Canada quietly got updated in December 2020. The new regulation intends to boost post-market safety and requires manufacturers to submit a summary report, which is similar to the post-market Periodic Benefit-Risk...
Read More -
R&Q's Christine Santagate Featured in Medical Design & Outsourcing
on 3 August 2016 | By Stephen Biernacki
Staying at the forefront of the medical device industry takes work - a lot of it, in fact. Communication with R&Q's peers in the industry is in large part how our employees do it, and a big part of that is addressing hot topics in the industry. R&Q's own Client Solutions Advisor...
Read More -
The Med Device Industry (and the FDA) Embrace 3D Printing Innovation
on 25 May 2016 | By Kate Keverline
Just this week the world's first 3D-printed office opened in Dubai. It took all of 17 days to print a 2,700-square-foot building at half the price of conventional methods. In short, this 3D printing thing has some legs... and we mean that literally, too. 3D printing is...
Read More -
Pediatric Subpopulations – Final Rule
on 22 January 2014 | By Ryan Kasun
On Friday, January 10, 2014 the FDA issued a final rule, which amends the premarket approval (PMA) regulations. The final rule requires “submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat”. 1 The...
Read More -
FDA gives Voice to the People
on 11 October 2013 | By Ryan Kasun
The Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) has launched a new initiative targeted at giving the patients a voice in the agency’s decision making process on medical devices. I became aware of this effort by the FDA when...
Read More -
Canada | Change In Contract Manufacturer | Health Canada | Medical Device | License Amendment Fax Back Form | Registration Triggers | Registration | Change In Country Of Origin
License Amendment Triggers in Canada
on 2 October 2013 | By Ryan Kasun
Sometimes changes in process can have a dramatic effect on product registration. There are several events that can cause a re-registration of a registered medical device. A new product name, part number, material, manufacturing site, country of origin, business name or...
Read More -
Biosense | 21 Cfr | Fda Guidance | Mobile Medical Applications | Fda | Medical Device | Submission Type | Mobile Application | Medical Applications | Regulatory Strategy | Medical Application
Mobile Medical Applications: Make Sure uChek with FDA
on 19 July 2013 | By Ryan Kasun
The latest mobile medical application news on the industry's collective mind is the issuance of an "It has come to our attention..." letter sent to Biosense Technologies in India, essentially questioning why Biosense has not obtained 510(k) clearance for their uChek mobile...
Read More -
Submissions | Fda | Medical Device | Team Members | Regulatory | 510(K) | Approval Time | Medicaldevice | Customer Success | Collective Experience | Regulatory Professionals | Fda Clearance
510(K) Success!
on 3 June 2013 | By Ryan Kasun
RQS team members pride ourselves on focusing on customer success, and it is with that in mind that I am honored to announce our most recent 510(K) submission was approved this week! We are proud to obtain clearance, but swell with pride because of how we obtained it.
Read More -
Medical Device Report | Complaint Handling | Medwatch | Complaints | Fda | Medical Device | Mdr | Adverse Event | Post Market Vigilance
Complaint Handling Solutions
on 23 May 2013 | By Ryan Kasun
In my last post “Who’s watching your MedWatching”, I commented on some of the common issues manufacturers have with their MDR and complaint handling systems. It’s useful to know what people are doing wrong, but I think it is equally important to know how to solve those issues....
Read More -
Using AGILE in Medical Device Software Development
on 17 May 2013 | By Ryan Kasun
In school I was always taught that the medical device development process followed the waterfall model. However since entering the work force I have started to see other methods of development for different types of devices. I have recently been working with software medical...
Read More -
Medical Device Report | Complaint Handling | Warning Letter | Medwatch | Complaints | Fda | Medical Device | Mdr | Adverse Event | Post Market Vigilance
Who’s watching your MedWatching?
on 3 May 2013 | By Ryan Kasun
Last year, FDA received almost one million adverse event reports from manufacturers1. Needless to say, the Office of Surveillance and Biometrics has been very busy, and so have manufacturers.
Read More -
Harmonized Symbols | Medical Devices | Medical Device Labels | Standards Development Organization | Labeling | Regulators | Labeling Products | Fda | Medical Device | Labels | Regulatory Structure | Biological Product | Sdo
Crash Those Symbols - FDA Proposed Rule
on 24 April 2013 | By Ryan Kasun
Make some noise people - the FDA may be making labeling easier on the medical device and biological product industries by way of harmonized symbols!
Read More -
Shock | Fda | Medical Device | Tachycardia | Fibrillation | Electrodes | Sudden Cardiac Arrest | Cardiac Emergency | Electrode Pads | Heart Rhythms | American Red Cross | Aeds
Proposed Order on AEDs
on 23 April 2013 | By Ryan Kasun
Automated external defibrillators (AEDs) can save the lives of individuals suffering from a cardiac arrest event. Sudden cardiac arrest can happen to anyone and at any time. According to the American Red Cross, over 350,000 people will suffer from sudden cardiac arrest this...
Read More -
Hpfb | Medical Device Companies | Wikipedia | Money | Tga | Regulatory Risk | Medical Device Industry | Investors | Fda | Medical Device | Anvisa | Engineering Projects | Open Source Projects | Crowd Source
Crowd Source in Medical Devices?
on 17 April 2013 | By Ryan Kasun
Collaborative development, or for the purposes of this post we'll call it "crowd sourcing", seems to be discussed and used more frequently in the current business environment. Obviously, crowd sourced projects have been around for a long while (Wikipedia is just one well-known...
Read More -
Mammogram | Medical Devices | Mammograms | Usability | Medical Device | Breast Cancer Screening | Human Factors | Regulatory | Women In Bio | Quality | Breast Cancer
Human Factors
on 16 April 2013 | By Ryan Kasun
Recently I had to get my annual mammogram. They were running behind like doctor’s offices sometimes do - there were seven women in dressing gowns in the waiting room with me. After a few awkward moments, we all started to talk to each other. Every single one of the ladies talked...
Read More -
Investors | Patent | Patent Application | First To File | Medical Device | Patent Office | Law | Innovation | First To Invent | Us Patent Law | Patent System
Patent Law Changes
on 11 April 2013 | By Ryan Kasun
For over 200 years, the US has operated under a “first to invent” rule. This means that if two innovators independently submit a patent for the same exact invention, the person who can prove that they invented it first is the one who is awarded the patent.
Read More -
Ergonomics Society | Alarms | Usability | False Positives | Alarm Systems | Medical Device | Iec 60601 | Human Factors
An Alarming Trend
on 10 April 2013 | By Ryan Kasun
If you’ve ever spent any appreciable amount of time in a hospital or other medical care facility, you may have been driven temporarily insane by the never-ending chorus of medical device alarms. I was recently reminded of a few nights I spent in the hospital with my dad a year...
Read More -
Audit Training
on 5 April 2013 | By Ryan Kasun
I recently had the opportunity to receive some training in auditing of medical device companies. In this training I was able to gain experience from an auditor's perspective as well as an auditee's perspective on how an audit is performed. This training was important to me...
Read More -
Excise Tax | Budget Resolution | Bipartisan Vote | Medical Device Manufacturers | Us Senate Committee | Senate Committee On Finance | U S Senate | Fda | Medical Device | Bipartisan Support | Government | Affordable Care | Medical Device Tax | Bipartisan
Bipartisan Repeal of Medical Device Excise Tax
on 2 April 2013 | By Ryan Kasun
Bipartisan support, in today’s world of politics, might seem a little hard to believe. However, the U.S. Senate passed an amendment that repeals the medical device tax last month (Thursday, March 21, 2013). The bill was passed by a bipartisan vote of 79 to 20. 1 This impressive...
Read More -
Medical “Wow”: 3D Printed Skull
on 28 March 2013 | By Ryan Kasun
Last week I saw several articles published about a new device that is going to shake up the Craniomaxillofacial device market, and the Orthopedic market is next on the list. 3D Printing – chances are you’ve just started hearing about it, mostly concerning gun controls laws for...
Read More -
Correction | Medical Devices | Warning Letter | Fda Inspection | Immediate Action | Fda | 483 | Medical Device | Corrective Action
RQS Feature Article - Successfully Addressing Warning Letters
on 22 March 2013 | By Ryan Kasun
Regulatory and Quality Solutions is featured in another publication this week! Our President, Maria Fagan, has written an article focused on the top five tips on how to successfully address FDA warning letters. The article is featured in MedCity News and can be found here. FDA...
Read More -
Device Submissions | Medical Device | American Medical Association | Pubmed | Guidance Document | Pma Supplement | Medical Product | Draft Guidance | Journal Of The American Medical Association
Open Comments are Not Left Unheard!
on 26 February 2013 | By Ryan Kasun
Some may think the FDA does not take what industry has to say to heart or feel that there is no point in commenting on a proposed rule, because their feedback is left unread.
Read More -
Medical Devices | Collaboration | Medical Device Companies | Partnership | Regulatory Science | Regulatory Pathway | Nih | Fda | Mdic | Medical Device | Innovation | Fda Regulated Products | Medical Device Innovation | Governing Bodies | Innovations
Regulatory Science
on 26 February 2013 | By Ryan Kasun
I heard an interesting new term today (new to me at least!) that I thought greatly impacts the line of work I am in. Regulatory science is "the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated...
Read More -
Da Vinci | Medical Device Industry | Technology | Medical Device | Technology Advancements | Surgery System | Robot-assisted | Intuitive
Technology Overkill?
on 22 February 2013 | By Ryan Kasun
Over the past few years, there have been some really great technologies that have changed the way we live our lives. Smartphones are the easiest example. Life would be a lot different if I didn’t have instant access to my e-mail, the weather, the spinning schedule at my gym, or...
Read More -
Adverse Events | Medical Devices | Quality Engineering | Regulatory Affairs | Design Quality | Mhra | Risk Management | Medical Device | Maude Database | Design Dossier
Regulatory Thoughts
on 19 February 2013 | By Ryan Kasun
Up until the time when I joined the RQS team in November all I had ever truly worked on was Quality. Coming out of college I worked for a plastics bottling manufacturer in process development and quality control. My next job was design V&V closely followed by design quality...
Read More -
New Medical Devices | Medical Device Industry | Medical Device | Regulation | Sensors | Innovations | Medical Breakthroughs
New Medical Devices Coming Soon to a Hospital Near You
on 18 February 2013 | By Ryan Kasun
Recently I came across a FoxNews article (‘Medical breakthroughs on the horizon for 2013’ by Dr. David Samadi) that got me excited. The reason why I pursued the medical device industry was to be in a field that impacted people; a field that matters. I don’t care who you are –...
Read More -
Making Sense of Standards
on 7 February 2013 | By Ryan Kasun
You may have heard that last year there were two new releases of EN standards: EN ISO 14971:2012 and EN ISO 13485:2012. What does this mean to you? What are the changes? How much does this affect the way you do business? Compliance to standards can be somewhat overwhelming....
Read More -
Medical Device Industry | Taxes | Fda | Medical Device | Public Health | Govenment | Regulatory | 510(K) | Cdrh
Headaches
on 7 February 2013 | By Ryan Kasun
The FDA received funding to increase its workforce at the CDRH for 2012 and 2013. They have set aggressive goals to improve the turnaround times for 510K approval. They have instituted programs to retain their employees and to increase the reviewer to manager ratio. My...
Read More -
Final Rule - Combination Products
on 30 January 2013 | By Ryan Kasun
Last week, the FDA issued a final rule(1-2) on combination products(3) and the applicable current good manufacturing practice (CGMP) requirements. The final rule actualizes the proposed rule that was issued many moons ago, in September 2009 without significant changes. Four...
Read More -
Iphone | Mhealth | Mobile Medical Applications | Healthspot | Android | Fda | Medical Device | Apps | Health Spot | 510(K) | Retinal Exam
Mobile Medical Applications - Where do we go from here?
on 28 January 2013 | By Ryan Kasun
With the recent announcement of 510(k) clearance of a retinal examining attachment and companion app can we now declare the outcry against the FDA finished?
Read More -
Adverse Events | Hip Replacement | Surgery | Safety Communication | Fda | Medical Device | Implantables
Hitting Home
on 18 January 2013 | By Ryan Kasun
One of the more personal aspects of why I work in regulatory and quality is because of my dad. As a youth, he experienced a hip injury. Combine that with a condition (don't ask - I never remember its fancy medical name) that causes weak capillaries, and that resulted in a...
Read More -
Preparing For Fda Visit | Regulatory Harmonization | Remediation | Australia | Fda | New Zealand | Medical Device | Regulatory News | White Paper
Regulatory Intel - Jan. 14, 2013 Quick-Hits
on 14 January 2013 | By Ryan Kasun
A few quick notes I wanted to post while clearing my inbox of my "informative reading" emails from last week:
Read More -
Wellness Products | Watch Sensors | Mobile Medical Applications | Fda | Medical Device | Wearable Tech
Mobile Medical Applications - Healthcare at CES
on 14 January 2013 | By Ryan Kasun
So I wasn't kidding last week about wearable tech, which made the biggest splash at CES 2013, an annual consumer electronics expo. Coverage thanks to CNET.com.
Read More -
Rta | Submission | Fda | Medical Device | 510(K) Submission | 510(K) Review | Guidance Document | Refuse To Accept | 510(K)
New "Refuse to Accept" Guidance Document for 510(k)s
on 14 January 2013 | By Ryan Kasun
There has been much controversy about the new RTA FDA Guidance document titled "Refuse to Accept Policy for 510(k)s". The draft of this guidance was issued for review in August of 2012 and was recently released at the end of that year. However companies are still talking about...
Read More -
Mistake, I Think Not!
on 20 December 2012 | By Ryan Kasun
As a native Clevelander and lifelong (i.e. 47 years) Northeast Ohio resident, I have heard my fair share of “Mistake on the Lake (Erie)” jokes. Yes, it’s true the Cuyahoga River caught fire in 1969, the city has suffered from loss of jobs due to de-industrialization, there have...
Read More -
Biodegradable Circuits
on 19 December 2012 | By Ryan Kasun
When I first heard the words “biodegradable” and “electronic devices” together, especially in the context of nanotechnology and the medical field, the idea smacked ever so slightly of science fiction. You know, the sort of advancement that belongs in an era of teleportation and...
Read More -
Mdd | Eu | Label | Regulatory Affairs | Rqs | Labeling | Ifu | Fda | Health Canada | Medical Device | User Guide | Instructions For Use | Manual
Labels impact the device
on 17 December 2012 | By Ryan Kasun
During this holiday season, when presents are being packaged and shipped at high volumes, I thought it would be appropriate to talk about the importance of labeling.
Read More -
Call me a (Juris) Doctor!?
on 17 December 2012 | By Ryan Kasun
I was going to write about China Labeling this week, but I didn't feel like it!
Read More -
Biocompatibility | Mdd | Eu | Medical Devices | 10993-1 | Fda | Health Canada | Medical Device | Medical Device Directive | 10993
Biocompatibility - Simple, Right?
on 12 December 2012 | By Ryan Kasun
I’ve been working in regulatory for a company in which biocompatibility of device materials has been pretty straightforward and understood by all for many years. Annex A in ISO 10993-1 and FDA General Program Memorandum - #G95-1 is all you need. Check the chart for our device...
Read More -
In Your Face
on 11 December 2012 | By Ryan Kasun
My teenager works at a local eatery – I thoroughly believe the saying, “A good teenager is a tired teenager”. Besides, there is a lot to be learned from being in the work force.
Read More -
Mhealth | Mobile Medical Applications | Submission | Fda | Devices | Medical Device | Apps | Alivecor | Software | Predicate | Mobile Medical Apps | Ekg | 510(K)Mobile Medical Applications - Community Bull-Dozers
on 6 December 2012 | By Ryan Kasun
Well how about that - software developers are making it easy on me to write this series with yet another 510(k) clearance announced this week. The latest in cleared mobile health devices? The AliveCor mobile heart monitor.
Read More -
Iphone | Mobile Medical Application | Mhealth | X Prize Foundation | Tricorder | Mobile Medical Applications | Android | Medical Apps | Fda | Medical Device | Scanadu | Star Trek | Apps | Blackberry | 510(K) | Qualcomm | Ios
Mobile Medical Applications - Beam Me Up, Scanadu
on 30 November 2012 | By Ryan Kasun
In a fantastic case of science-fiction-meets-reality, Qualcomm created the X Prize Foundation to challenge developers and innovators to create a Star Trek Tricorder. The prize? $10M!
Read More -
Quality Systems | Production Quality | Design Quality | China | Fda | Medical Device | Regulatory | Quality
International Spotlight - China
on 29 November 2012 | By Ryan Kasun
When people ask my opinion of the most difficult country to register medical devices internationally, I would have to say it is China. China is considered to be an “emerging market”- it is getting more and more lucrative to register there as the population gets larger and...
Read More -
Rethinking Innovation
on 12 November 2012 | By Ryan Kasun
One of my favorite topics about the medical device industry and technology in general is innovation. Rebecca's post last week discussed the Medical Innovation Summit - "Innovative to the Bone" hosted by the Cleveland Clinic. Although I was unable to attend the event, I did find...
Read More -
Magnetic Resonance Imaging | Medical Imaging | Mobile Medical Applications | Mma | Mri | Medical Device | Computed Tomography | Ipad Medical Apps | Picture Archiving Communication System | Teleradiology | Mobile Medical Apps | Aycan Mobile | Pacs
Mobile Medical Applications - Aycan 510(k)
on 9 November 2012 | By Ryan Kasun
To continue our product highlights within mobile health, we turn to Aycan's "Aycan Mobile" product which received clearance on September 12, 2012. A picture of its use on an iPad is shown on their website.
Read More -
Stay out of Frying Pans and Fires!
on 9 November 2012 | By Ryan Kasun
Quick note today as a training seminar came through my inbox.
Read More -
Searching for Medical Device Info
on 5 November 2012 | By Ryan Kasun
As a recently new professional in the medical device industry, I try to find any tips or tools I can use to gain more knowledge about the industry as a whole. Increasing my general knowledge of the field can only help me when I interact with other professionals. When thinking of...
Read More -
Iphone | Touchscreen | Mobile Medical Applications | Usability | Buttons | Medicaldevices | Android | Medical Device | MedicaldeviceMobile Medical Applications - Difficult Usability?
on 5 November 2012 | By Ryan Kasun
The topic of this week's post was a bit more challenging than normal. Ever since my inadvertent "reboot" of the Everyday Usability series, my brain was stuck in that frame of mind. Even today I struggled to break my mind from it.
Read More -
Conducting a Literature Review
on 30 October 2012 | By Ryan Kasun
One issue that came up last week with a client was how to conduct a literature review and how important literature reviews were. I have experienced in some cases, companies that have a lot of man power behind the reviews but these companies do not have solid criteria for...
Read More -
Mdd | Eu | Europe | Medicaldevices | Medical Device | European Union | Medical Device Directives | Ivd | Medicaldevice | Active Implantable Medical Device
Overview of New Medical Device Regulations in Europe
on 26 October 2012 | By Ryan Kasun
This week my inbox was flooded by notifications of a great blog post from the Emergo group, outlining the changes set to occur to the medical device regulations in Europe. Changes such as:
Read More -
Everyday Usability | Landfill | Usability | Medicaldevices | Starbucks | Medical Device | Trash | Green Movement | Medicaldevice | RecyclingBlast from the Past - Everyday Usability
on 26 October 2012 | By Ryan Kasun
I couldn't resist the urge to post another picture in the Everyday Usability series after seeing this:
Read More -
Mhealth | Idiom | Mobile Medical Applications | Mma | Medicaldevices | Medical Device | Apps | Titanic | Medicaldevice
Mobile Medical Applications: Titanic Chairs
on 26 October 2012 | By Ryan Kasun
I've often believed that the number of idioms and quirky phrases describing a particular characteristic, event, or circumstance is mostly equivalent to its frequency in everyday life.
Read More -
Keeping up with Standards
on 23 October 2012 | By Ryan Kasun
With recent clients I have been dealing more and more with new standards coming out or revisions being made to standards. This has got me thinking a lot about how to keep up with current standards. What is the best way of being notified of new releases of standards as well as...
Read More -
Mhealth | Medical Devices | Mobile Medical Applications | Windows 8 | Mma | Medicaldevices | Android | Medical Device | Mobile Medical Apps | Medicaldevice | Ios
Mobile Medical Applications: Whale Cupcake
on 19 October 2012 | By Ryan Kasun
A good friend of mine in high-school was trying to understand the definition of a "hyperbole". Now, if Google would have been sophisticated enough at the time to include the "define:" feature, it would have returned the following for hyperbole: Exaggerated statements or claims...
Read More -
Medical Devices in Different Markets
on 16 October 2012 | By Ryan Kasun
I recently took a two week vacation to South Africa traveling to Cape Town, Prince Albert and various parts of the northern Western Cape. It was an absolutely amazing trip with many memories of time spent with my family. Traveling to a foreign country has shown me a lot of new...
Read More -
Medical Device Tax: Funding Healthcare for Millions
on 12 October 2012 | By Ryan Kasun
In the second of the two part series, we'll review support of the 2.3% tax of the medical device industry to go into effect on January 1, 2013. Earlier this week, I outlined why the industry sees this tax as an enormous burden and described actions already being taken to off-set...
Read More -
Now that’s some real horse power
on 11 October 2012 | By Ryan Kasun
Our neighbors located up the street from our Cleveland, OH location, at the Cleveland Clinic, have recently helped develop horse power into a whole new meaning. A Cleveland Clinic researcher found that one reason horses are more efficient at walking and running than humans, is...
Read More -
Medical Device Tax: Windfall or Pitfall?
on 9 October 2012 | By Ryan Kasun
Thanks to Sherri's earlier post, we've begun to explore the landscape of the medical devices industry in reaction to the 2.3% tax on revenue for medical device companies as a result of the Affordable Care Act. The tax is being implemented in part to fund the estimated 30 million...
Read More -
Creating Consistency
on 8 October 2012 | By Ryan Kasun
One major variable med tech companies are faced with today is the unknown of FDA reviewers. It seems like what works for one company doesn’t necessarily work for the rest. And why is this so?
Read More -
Occupational Safety And Health | Osha Guidelines | Mdd | Eu | Medical Devices | Intuitive Responses | Design Considerations | Usability | Interaction | Occupational Safety And Health Administration Osha | Environments | Fda | Health Canada | Medical Device | Occupational Safety And Health Administration | 510(K) | Environmental Conditions
Mobile Medical Applications: Mobile Medical Device Design
on 3 October 2012 | By Ryan Kasun
Many medical devices are meant to be used while in mobile situations. These devices could be wearable, carried in a user’s pocket or by hand, pushed like a cart, etc. Users of mobile medical devices expect them to be safe, reliable, durable, and easy to use while in motion or...
Read More -
Iphone | Mhealth | Diabetes | Glucose Measurements | Mobile Health | Mobile Medical Applications | Electronic Log Book | Regulatory Department | Android | Fda | Medical Device | Regulatory News | Apps | Design Engineers | Device Manufacturers | Glucose Monitor | Medical Application | Fda ClearanceMobile Medical Applications: Falling Star?
on 26 September 2012 | By Ryan Kasun
I think it's high time we start profiling a few applications that have been approved for use by the FDA, discuss their functionality, and potentially profile the impending issues they may encounter.
Read More -
Nanomaterials | Medical Device Industry | Medical Device | Nanotechnology | Fdasia | Med-tech Industry
Nano-what? Nanotechnology.
on 5 September 2012 | By Ryan Kasun
Over the past 50 years, the advancement of technology has been beyond incredible. Although, we are not zipping around in flying cars, fearing the dreaded encounter with a hoverboard gang, or living amongst cyborgs, we are witnessing things never before thought possible. Such...
Read More -
Medical Images | Software Developers | Submissions | Regulatory Effort | Image Viewing Software | Diagnosis | Computer File | Ipad | Regulatory Pathway | Submission | Fda | Medical Device | Image Credit | Barco | Press Release | Calibration | Medical Applications | 510(K) | Princeton | Job | Fda Clearance
Mobile Medical Applications: Visual Calibration
on 2 December 2011 | By Ryan Kasun
Our third installment of the mobile medical apps series finally features a mobile medical app. This app in particular, the MediCal QAWeb Mobile app, is used to calibrate the screen of an iPad for diagnosis of medical images viewed on said iPad (both versions 1 and 2 according to...
Read More -
Iphone | Mdd | Mhealth | Medical Devices | Mobile Health | Mobile Medical Applications | Mma | Fda | Medical Device | Mobile Medical Apps | 510(K)
Mobile Medical Applications: Cyber Security
on 28 November 2011 | By Ryan Kasun
As with all software and technology, security is, and will always remain, a hot-button topic. It is even a point of contention for computer consumers - Mac vs. PC debates often will focus on how Mac's don't "need" virus protection (which is somewhat of a misnomer, but certainly...
Read More
We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.
GLOBAL BOTTOM CTA INSTRUCTIONS:
To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.
Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!
.svg "white RQM logo")
