MIXOLYDIAN
Starting to get Involved
Marcelo: Do you know how I can find out what is the classification for a Hearing Aid (medical device) in Brazil? I checked ANVISA website but had no results.
Thanks.
Thanks.
Does anyone know how long does it usually takes for the INMETRO Certification Process in Brazil, consider as a Class II Active Medical Device already have a valid IEC 60601-1 test and the IEC 60601-2-xx Particular?
Regarding the N 09 / 2013, for our device, the corresponding "IEC 60601-2-xx Particular" is not found on the list, does anyone has experience or recommendation to tackle this?
Is the RDC 16 an almost direct lift of the 21 CFR part 820 ... ?
The MDSAP QMS Manual is the QMS manual for the MDSAP program (for use by regulators), not for use of manufacturers applying the program.
The MDSAP Quality Management System (QMS) provides guidance to:
(1) Design and develop processes, products/outcomes, and services related to the MDSAP’s mission, and to critical management and administrative support services, and
(2) Continually improve and strengthen product/outcome and service quality.
This MDSAP Quality Management System Manual contains the required information to implement quality principles and practices throughout MDSAPs sites. The anticipated audience for this manual includes those in the public, regulated industry, counterpart agencies, and other MDSAP participants and members who wish to understand MDSAP QMS.
The MDSAP Quality Management System (QMS) provides guidance to:
(1) Design and develop processes, products/outcomes, and services related to the MDSAP’s mission, and to critical management and administrative support services, and
(2) Continually improve and strengthen product/outcome and service quality.
This MDSAP Quality Management System Manual contains the required information to implement quality principles and practices throughout MDSAPs sites. The anticipated audience for this manual includes those in the public, regulated industry, counterpart agencies, and other MDSAP participants and members who wish to understand MDSAP QMS.