This weekend my family and I are going to go to the Congenital Heart Walk at 9:45 a.m. at the boathouse in North Park. This walk is to raise awareness for Congenital Heart Defects, America’s #1 birth defect. Regulatory and …
Category Archives: News
Regulatory Intelligence
Posted 6 days ago byHow much time to you spend searching FDA’s website? Looking for predicates, collecting adverse event reports from the MAUDE database, searching for guidance documents, etc. I’m sure I don’t need to dig into the details, you have felt this pain …
Posted in News
Tagged FDA, FDA website, Graematter, regulatory, Regulatory Intelligence, software, www.fda.gov
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Every time I visit my optometrist I see advertisements for colored contact lenses. I’m pretty happy with the green I’ve got so I’ve never tried another color. Did you know that contact lenses, even the purely decorative ones that don’t …
Posted in News
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Consumer Medical Device Adverse Event Reporting
Posted 6 days ago byRecently I went trolling through the FDA website and stumbled upon an article entitled “Wanted: Consumers to Report Problems (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm354560.htm#report). It’s a great article that at its core, is a plea to the consumers of medical devices to aide in the …
Posted in Architect of Quality, Articles, News, Regulatory Intel
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Integration Phase – AGILE vs. Regulatory
Posted 6 days ago byAn AGILE software development process allows for adaptive development through incremental changes in the software. This means that there are more releases and upgrades of the software in the field. Within the AGILE process there is time allotted for the …
Race for the Place and RQS Cares
Posted 14 days ago byAfter reading Steve’s blog, “Why RQS Cares- The Race for the Place” and learning more about Race for the Place/The Gathering Place, I knew that I wanted to participate in this event. Soon thereafter, I was registered and ready to …
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510(K) Success!
Posted 17 days ago byRQS 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 …
Posted in News
Tagged 510(k), approval time, collective experience, customer success, FDA, fda clearance, medical device, medicaldevice, regulatory, regulatory professionals, submissions, team members
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Could it get much worse for mobile medical applications and their developers trying to utilize phones and tablets as point-of-care medical devices? OK, surely it could, but this story can’t make it any easier. As this Bloomberg article reports, a …
Posted in Mobile Medical Applications, News
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FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device
Posted 22 days ago byThe FDA is looking for industry input for the revision of FDA 510(k) Memorandum #K97-1 “Deciding When to Submit a 510(k) for a Change to an Existing Device,” January 10, 1997. This is a critical go-to document for the average …
Posted in News, Regulatory Intel
Tagged 510(k), FDA, Guidance Document, K97-1, medical device industry, Medical Devices, regulatory
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Complaint Handling Solutions
Posted 28 days ago byIn 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 …
Posted in News
Tagged Adverse Event, Complaint Handling, Complaints, FDA, MDR, medical device, Medical Device Report, MedWatch, Post Market Vigilance
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