Informational New Notified Body designated under the MDR – TÜV SÜD Product Service GmbH Zertifizierstellen

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M Informational EU – New notified body designated under the MDR – NB 2797 BSI Group The Netherlands B.V. Netherlands Medical Device and FDA Regulations and Standards News 0
M Informational EU – New notified body designated under the MDR – NB 1912 – DARE!! Services B.V. – Netherlands Medical Device and FDA Regulations and Standards News 0
M Informational EU – First IVDR designated Notified Body – DEKRA Certification GmbH Medical Device and FDA Regulations and Standards News 0
M Informational EU – New designated Notified Body under the MDR – TÜV Rheinland LGA Products GmbH Medical Device and FDA Regulations and Standards News 0
M Informational New designated Notified Body for Regulation (EU) 2017/745 (MDR) included in Nando – IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Medical Device and FDA Regulations and Standards News 3
M Informational EU – Next Notified Body designated to the MDR 2017/475 is IMQ S.p.A from Italy Medical Device and FDA Regulations and Standards News 0
M Informational EU – DEKRA Certification GmbH is the third Notified Body designated under the MDR Medical Device and FDA Regulations and Standards News 0
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 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
R Notified Body for MDD 1Q20 - Florida Company Registrars and Notified Bodies 4
N Customer asking if their notified body can audit us ISO 13485:2016 - Medical Device Quality Management Systems 5
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
Ed Panek CAPA against Notified Body? EU Medical Device Regulations 5
N Regular meetings with Notified Body EU Medical Device Regulations 13
JoshuaFroud The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status CE Marking (Conformité Européene) / CB Scheme 1
M Measurement Unit Rounding Nonconformity - Notified Body Audit Registrars and Notified Bodies 6
M Informational From RAPS – Another Notified Body Bows Out Ahead of EU MDR: ‘Investment Too High’ Medical Device and FDA Regulations and Standards News 2
M Authorized Rep (AR), competent authority, NCA and notified body - Differences EU Medical Device Regulations 9
R How long to wait for Notified Body Response - Potentially significant change to a medical device CE Marking (Conformité Européene) / CB Scheme 6
shimonv Non-significant notice of change to notified body EU Medical Device Regulations 4
S Difficulty Finding A Notified Body for CE Marking - No Capacity Registrars and Notified Bodies 5
P Notified body located in an other country than manufacturing company ISO 13485:2016 - Medical Device Quality Management Systems 2
M BSI – Want to know more about the Notified Body? Registrars and Notified Bodies 0
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
M Medical Device News BSI achieves Designation for its Netherlands Medical Devices Notified Body EU Medical Device Regulations 2
C Attestation of QA certificate from foreign (EU) Notified Body Other Medical Device Regulations World-Wide 6
D Notified body - CE Certification Class 2a Products in India CE Marking (Conformité Européene) / CB Scheme 4
M Notified Body Involvement with Self Declared Products EU Medical Device Regulations 7
C QR Code on Medical Device Packaging and Notification to Notified Body EU Medical Device Regulations 1
H Clinical investigation - Role of Notified Body (NB) EU Medical Device Regulations 6
S Certification Body, Registrar, Notified Body - What is the difference? Registrars and Notified Bodies 3
D CE Mark with same NB (Notified Body)? CE Marking (Conformité Européene) / CB Scheme 4
Sam Lazzara Expedited, fast-track Notified Body Technical File reviews EU Medical Device Regulations 3
Sam Lazzara Notified Body CE Project Manager - Worst job ever? EU Medical Device Regulations 6
K Notified Body - Minor Nonconformances - They have withheld all certificates General Auditing Discussions 3
R Non-Conformity Report from Notified Body - MEDDEV Guide is not Legally Binding EU Medical Device Regulations 16
JoCam Required Frequency of Notified Body reviews of Technical Files EU Medical Device Regulations 6
R ISO 13485 Certificate Scope modified by Notified Body EU Medical Device Regulations 9
S Literature Search - Notified Body Had Questions About our Rationale CE Marking (Conformité Européene) / CB Scheme 9
M Notified Body (NB) Audits of Sub-Contractors and Critical Suppliers EU Medical Device Regulations 35
C Class I Reusable Surgical Instruments - CE Mark with the Notified Body number EU Medical Device Regulations 14
R Which Notified Body to Choose in the EU EU Medical Device Regulations 7
C Moving to a different Notified Body Quality Manager and Management Related Issues 5
A What to expect in a Design Dossier Review for CE Marking by a Notified Body CE Marking (Conformité Européene) / CB Scheme 3
D Experience with Notified Body - ITC from Czech Republic for Medical Devices Registrars and Notified Bodies 15

Similar threads

Top Bottom