MedTech Review, LLC @MedTechReview
Medical Device Regulatory and Compliance Experts medtechreview.com Convenient to AZ, CA, CO, UT Joined October 2010-
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Brazil's ANVISA, announced significant revisions to its Resolution of the Collegiate Board of Directors (RDC) 185/2001, dealing with the registration of medical device. Will go into full effect March 1, 2023. hubs.li/Q01mZ4l80
The @US_FDA is seeking comment on conducting remote regulatory assessments. hubs.li/Q01lb8lK0
Looking to register your #medicaldevice in the UK? Here is a link to a ton of good information! hubs.ly/H0DdvG-0
FDA finalizes exemptions for certain devices from 510(k) review ow.ly/NiDo50xLzgg #fda #devices #510k
🎓MDR TRAINING🎓 PRRC Course Don't miss the chance to get some valuable insights from our experts on: - MDR & #IVDR - Conformity Assessment Procedure - #UDI system & MD nomenclature Early bird registration ends next week👉 zcu.io/xV2x
EU-MDR GSPR#4 diverges from EN ISO 14971:2012 by allowing manufacturers determine which residual risks to disclosed. What about "information for safety"? Under GSPR#4, do you consider information for safety as a mitigating or non-mitigating risk control?
Just because a product is used in a healthcare environment or by a healthcare professional, does not automatically mean it is a medical device. lnkd.in/gP6DyqJ
The Singapore Medical Device Register (SMDR) is a database of all medical devices registered for use in human being under the Health Product Act (Medical Device Regulation). The SMDR is open to all. hsa.gov.sg/content/hsa/en…
Great information for all of us planning the transition!
Great information for all of us planning the transition!
IMDRF's UDI Working Group's guidance provides globally harmonized approach for regulatory authorities who intend to develop their #UDI systems. Public consultation on the proposed guidance closes 12 October 2018. imdrf.org/consultations/…
From a Notified Body review of a Clinical Evaluation Report ... "the CER presented PMS/complaint data and registry data for your particular devices; however, complaint data does not represent evidence of clinical performance"
Belgian Medical Competent Authority abolishes submission TAXES! This is good news for all #MDD #IVD manufacturers represented by Obelis, but also for any new manufacturer wishing to enter the #European market. ow.ly/sKW530kXR8Y
FDA intends to forego conducting a preapproval inspection for PMA devices. lnkd.in/g-VnNkm
Case for Quality Pilot Activities lnkd.in/g-VnNkm
Nine companies selected out of 103 applications to pilot newest FDA regulatory venture that focuses on firms and dev…lnkd.in/gKEw4rt
"Reduction of information for pre-market approval on software as medical devices" linkedin.com/pulse/reductio… by @MedTechReview on @LinkedIn
Ready to get busy? The new EU Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulati…lnkd.in/da_ftDw
#RAPS has sector-specific versions of Fundamentals of Int'l Reg Affairs book & allows focus on areas you need to become RAC (Global)
"'E-label SYMBOL' for medical devices" linkedin.com/pulse/e-label-… by @MedTechReview on @LinkedIn
Med-Tech Innovation @medtechonline
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EU new Medical Device Regulations (MDR) AAMI/BSI Conference - Events 9,10 March 2016 Herndon VA USA - AAMI aami.org/events/Content…
I'm Alfie and I've been taking over Hootsuite's Instagram for the week! Check it out 👉 ow.ly/ZjXSj`
New ISO 13485:2016 affects every link in medical manufacturing supply chain ow.ly/Zk6GB @MedTechReview ow.ly/i/htFjX
@MedTechReview Going to do that now, John. We just launched our new website and have been encountering a few hiccups. Thanks for RTs!
New #ISO13485 affects every link in medical manufacturing supply chain. Find out how ow.ly/YUwYM ow.ly/i/haawd
Evonik’s VestaKeep PEEK validated by Surface Dynamics for titanium coating #MedDevice businesswire.com/news/home/2016…
#RepublicanDebate: Kasich gives shout out to Ohio's medtech industry ow.ly/YNGBY @JohnKasich ow.ly/i/h5hwy
Shall we wait for the EN version though perhaps? > ISO 13485:2016 - Medical dev... iso.org/iso/home/store… @msuets @MedTechReview @LinkedIn
Oh...... > "The countdown ends! " by @MedTechReview on @LinkedIn linkedin.com/pulse/countdow…
Make a list. Check it twice! Join #CDCFoodChat Wed (12/9) @ 2PM ET for holiday tips from CDC & #foodsafety partners.
Today is the first day of #2015RAPS workshops. Welcome, participants. Have a great day!
Thank you for following us: @BioRadCareers,@PCGSoftware,@shoshbu,@MedTechReview,@medtechengine
Proud to be part of this team! x.com/medtechreview/…
We look forward to attending @RAPSorg Regulatory Convergence in #Baltimore 10/24-28. We're in the exhibit hall, booths T4 & T5. #2015RAPS
Look forward to seeing you in Baltimore! x.com/medtechreview/…
We look forward to attending @RAPSorg Regulatory Convergence in #Baltimore 10/24-28. We're in the exhibit hall, booths T4 & T5. #2015RAPS
#2014RAPS Come visit us booth 415 @GraematterInc. Good day in Austin. Thanks 2 the RAPS team 4 pulling this 2gether
3D skull implant at #2014RAPS Recently cleared by FDA, made by Oxford Performance Materials.
Business group says biopharmaceutical industry is good medicine for New York's economy http://bit.ly/q5GjH3