Whether MEDDEV guidance book will be useful for MDR transition? (It is released by RAPS)
Is this book includes all MDR sections with detail explanations?
Reference Link: https://www.meddevsolutions.co.uk/the-mdr-guidebook
If anyone already bought this book suggest how much worth of...
Dear all,i want you to advice me, what is better to get a IRCA ISO 13485 certification or to get a RAPS , i´m not talking about the content, i want to know about the chance to get a better job with this kind of certification.
Thanks in advance.
Any good resources to prep for the RAC exam that don't cost an arm and a leg? I've paid to become a member and to take the certification program but would just feel more comfortable with actual test prep.
I am interested on getting a Regulatory Affairs Certificate (Medical Device & Pharmaceuticals).
I searched a lot and I found out that Regulatory Affairs Professionals Society (RAPS) offers exactly what I am looking for. However, I would like to know if anyone heard about (RAPS) and their online...
This convenient list of website addresses was published by RAPS:
I am newbie to Regulatory Profession as well to Elsmar!!!
I find this forum of immense help for newcomers like me.
Would you help me in guiding as to how and where I can get more knowledge about this field! Also suggest me reading materials that are easily available on net..
Registration has opened for the 18th AHWP Meeting and 1st AHWP -RAPS Joint Conference.
Event dates: 2-5 Dec 2013
Location: Petaling Jaya, Selangor, KL, Malaysia
Early bird registration by 2 Nov 2013
Below is the url for more details:
Very interesting, but would it really help or just add more red tape?
There is a RAPS article on FDA Inspections and Enforcements that summarizes the 2011 FDA Warning Letters, top ten deficiencies for Drugs, Devices, and number of domestic and foreign inspections, etc..
See attached presentation.
Top ten medical device deficiencies according to FDA...
The Global Harmonization Task Force (GHTF), a global regulatory body whose duties are set to be assumed shortly by the International Medical Device Regulators Forum (IMDRF), has released a final guidance document on its N54:2006 adverse event data reporting standard.
:read:ANVISA strike to delay medical device reviews in Brazil
htt p :// www .massdevice .com/blogs/arezu-sarvestani/anvisa-strike-delay-medical-device-reviews-brazil - OBSOLETE BROKEN 404 LINK(s) UNLINKED
ANVISA Announces Continuity Measures for Medical Device Importers During Strike
Pls give me your valuable advice.
I am considering to take the RAC exams and to initiate the registration of drug and food supplements from Asian countries with Health Canada and USFDA. In reviewing the preparation for the exams, I find it not clear to whether it is recommended to...
The Global Harmonization Task Force (GHTF), a medical device-focused regulatory harmonization organization which counts among its members many of the world’s top regulatory agencies, announced a new proposed medical device standard aimed at introducing a grading system to be used...