SBS - The best value in QMS software

Notified Body - Does anyone have experience using TUV Essex?

L

Larry Pool

#1
Does anyone have experience using TUV Essex. We are a small medical device company looking for a responsive notified body who provides a timely review of Design Dossier CE Mark applications and change notices.

Referals are welcome.

Larry
 
Elsmar Forum Sponsor
I

IEGeek - 2006

#3
I have never used TUV Essex, however TUV out of San Diego is great. I think that as a whole TUV is a great organization, and by letting them know up front in the quoting process you can help "push" them along to be as responsive as you need.

TUV out of San Diego was put under the gun with our latest CE project and completed it on time with no real hiccups to worry about.

Here is where I goofed up when I started the process.

"With the exception of some high-risk products, most products can be self- assessed by the manufacturer to meet the Essential Requirements. While CE Marking permits a product's access to the EU, it is not an approval certification or quality mark; nor is it intended to be a marketing tool. CE is a "Marking" that is only a declaration of the supplier's own responsibility. While enabling products to be placed on the European market, it only allows for the free movement of goods and permits the withdrawal of non-conforming products."
 
Thread starter Similar threads Forum Replies Date
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
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
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
M Informational EU – First IVDR designated Notified Body – DEKRA Certification GmbH Medical Device and FDA Regulations and Standards News 0
N Regular meetings with Notified Body EU Medical Device Regulations 13
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
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
M Informational New Notified Body designated under the MDR – TÜV SÜD Product Service GmbH Zertifizierstellen Medical Device and FDA Regulations and Standards News 1
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

Similar threads

Top Bottom