SBS - The Best Value in QMS software

Spanish Notified Body - Spanish language

marie luis murray

Starting to get Involved
#1
Dear all,

I would like to ask you if someone has any news related to when the Spanish Notified Body (NB) is expected to be designated under the Medical Device REgualtion?

We are in touch with a manufacturer that has almost all the information in spanish....

Therefore, I would also like to ask you if someone knows a NB in europe that also accepts the information for the CE MArk submitted in spanish


thanks a lot!

MM
 
Elsmar Forum Sponsor

Raisin picker

Involved In Discussions
#2
Dear marie luis, only agencia española de medicamentos y productos sanitarios can answer your first question, even if you ask it here in duplicate posts. Regarding your second question: I don't know one, and I can't imagine there is one. You have to look up and ask all 19 currently designated NBs, and wait for the other 20 or so to come.
 
Thread starter Similar threads Forum Replies Date
M Translate Procedures into Spanish Other Medical Device Regulations World-Wide 5
A AS9100 Rev:D in Spanish - where can I find a Spanish version? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
B Looking for Lean Manufacturing Articles in Spanish Lean in Manufacturing and Service Industries 4
I Where can I Get a Spanish Translation of TS 16949? IATF 16949 - Automotive Quality Systems Standard 2
R Where to find 21 CFR Part 820 Translated into Czech, Spanish, and German 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
V ISO 13485 certification scope in Spanish ISO 13485:2016 - Medical Device Quality Management Systems 5
B Requirements to have translations to Spanish for the Argentinian market certified Other Medical Device Regulations World-Wide 1
S Spanish Customs Claim: Has the MDD class to be mentioned in the DoC? EU Medical Device Regulations 5
M AIAG Automotive Documents in Spanish IATF 16949 - Automotive Quality Systems Standard 5
I ISO 9001:2000 - is Spanish translation of documentation required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
M Format for Translation of Controlled Documents into Spanish Document Control Systems, Procedures, Forms and Templates 7
V Instructions for Use - English into French, German, Italian, Spanish and Swedish Document Control Systems, Procedures, Forms and Templates 11
M Spanish PSW (Part Submission Warrant) Needed APQP and PPAP 8
M Dire need of a copy of AS9100:2004 in Spanish AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
R Booklet for ISO9001 training purposes - Preferably In Spanish Training - Internal, External, Online and Distance Learning 12
I QMS Translation from English to Spanish ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
CarolX Seeking Trade Magazine (like Quality or Quality Digest) in Spanish Book, Video, Blog and Web Site Reviews and Recommendations 2
Marc MSA Spreadsheet in Spanish - Cohen kappa method (circa 2006) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
M Any (free) copy of a TS 16949 checklist in spanish? IATF 16949 - Automotive Quality Systems Standard 6
Hershal MU course in Spanish - poll Training - Internal, External, Online and Distance Learning 1
A ISO 9001:2000 Employee Awareness Training Video in Spanish Training - Internal, External, Online and Distance Learning 2
A Needed: MSA (Measurement Systems Analysis) Terms translated to Spanish Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
R Training Available in Spanish? Training - Internal, External, Online and Distance Learning 1
Marc Todays Topic: Learn Spanish! Coffee Break and Water Cooler Discussions 5
CarolX translations to spanish Document Control Systems, Procedures, Forms and Templates 6
M QS standard in SPANISH? QS-9000 - American Automotive Manufacturers Standard 2
C Who offers QS9000 training (in Spanish) on topics like PPAP, FMEA, etc QS-9000 - American Automotive Manufacturers Standard 2
E SPANISH TOPIC - QS9K y el Tech Standar 16949 QS-9000 - American Automotive Manufacturers Standard 10
Marc Spanish Translations ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
M Supplier approved list - Notified body, regulatory body Supply Chain Security Management Systems 4
chris1price Notified Body responsible for product safety under MDD? EU Medical Device Regulations 4
H If we use agile - do we still need to document TF as a waterfall just for the notified bodies need? IEC 62304 - Medical Device Software Life Cycle Processes 2
Ed Panek Notified Body Substantial Change MDD EU Medical Device Regulations 1
M Spain Notified Body Medical Device and FDA Regulations and Standards News 0
M Notified Body Spain Other ISO and International Standards and European Regulations 0
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
P Notified Body Approval of Change EU Medical Device Regulations 2
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
A NB (Notified Body) Audit of Standards ISO 13485:2016 - Medical Device Quality Management Systems 3
J Conflict of Interest Registrar/Notified Body/Testing House Quality Manager and Management Related Issues 4
R Plea for advice on transitioning between Notified Bodies (label updates) Medical Device and FDA Regulations and Standards News 1
B Notified Bodies for Software (MDR) EU Medical Device Regulations 1
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
Watchcat "Disappeared" Linkedin Notified Body Rant EU Medical Device Regulations 2
M Notified Body audits -Class Ia medical device product EU Medical Device Regulations 4
Watchcat How Many Notified Bodies are "Enough" Already? EU Medical Device Regulations 23
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Y When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019? ISO 14971 - Medical Device Risk Management 1

Similar threads

Top Bottom