Which Medical Device Standard Registrar would you recommend?

Which Registrar would you recommend?

  • BSI

    Votes: 2 66.7%
  • LNE

    Votes: 0 0.0%
  • SEMKO

    Votes: 1 33.3%
  • NSAI

    Votes: 0 0.0%

  • Total voters
    3
  • Poll closed .

fcowdery

Starting to get Involved
#1
We were recently notified that our registrar no longer supports our device category.

We have 2 options for a new registrar, neither of which do I have prior experience: LNE, and BSI,

It would be helpful to our decision, if anyone can share their experiences with either registrar. (Good or Bad :D)

Tahnks in advance
 
Elsmar Forum Sponsor

GStough

Leader
Super Moderator
#2
Hello,

The only name in the list above with which I'm familiar is BSI. BSI is generally pretty good, from my experience. I have heard positive and negative from others who have used them, but my experience with them was positive.

I hope this helps.
:)
 

GStough

Leader
Super Moderator
#4
Without specifying which standard(s) it's difficult to reply.
Hi Marc,

Medical Device Standard (in the Thread Title) would be ISO 13485, but the OP didn't say which version, nor the type/class of medical devices. This would be helpful, as well. There may also be other medical device standards out there of which I may not be aware.
 
#5
We were recently notified that our registrar no longer supports our device category.

We have 2 options for a new registrar, neither of which do I have prior experience: LNE, and BSI,

It would be helpful to our decision, if anyone can share their experiences with either registrar. (Good or Bad :D)

Tahnks in advance
Assuming you're looking for an MDD Notified Body, you can search by device category on the Nando site. Search "EU Nando". Sorry, I'm not able to post the specific URL.
 
Thread starter Similar threads Forum Replies Date
U Leakage test Standard for Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
P Medical device testing lab/service standard Other Medical Device Related Standards 1
N Is there a standard / rules pertaining to eating in medical device manufacturing area? Manufacturing and Related Processes 5
P Usability/human factors engineering requirement (standard) for IVD medical device Other Medical Device Related Standards 2
G Electrical Safety standard for medical device not covered by IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Q JIS T 1115 Comparison (Japan Medical Device Standard) Japan Medical Device Regulations 0
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Document Control Systems, Procedures, Forms and Templates 12
S Medical Device Clinical Evaluation Standard Operating Procedure / SOP Imported Legacy Blogs 1
S Medical Device Reporting SOP (Standard operating procedure) example Other Medical Device and Orthopedic Related Topics 1
R Is there a mandatory medical device warehouse standard for europe? EU Medical Device Regulations 3
M Partial Compliance to an ISO Standard for Medical Device CE Marking EU Medical Device Regulations 13
J Quality Procedure to handle some standard Medical Device Processes Document Control Systems, Procedures, Forms and Templates 1
A Classification of Medical Device with Partial Compliance with a particular standard IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G Old Medical Device Equipment - Compliance with New or Old Standard - What to do? Other Medical Device Related Standards 3
W EN ISO 15225 (2010) - Medical Device Nomenclature - A Harmonized Standard? EU Medical Device Regulations 1
R Regulation/Standard for Labelling in the UK - Medical Device Directions for Use ISO 13485:2016 - Medical Device Quality Management Systems 7
E Reference Standard for Shelf Life Testing of Packaging for Sterilized Medical Device Other US Medical Device Regulations 3
Marc ISO 13485 - Medical Device Quality Management System Standard ISO 13485:2016 - Medical Device Quality Management Systems 30
D FMEA with 2 or 3 criteria? Standard applicable to the Medical Device industry ISO 14971 - Medical Device Risk Management 13
P Version of Medical device safety standard - IEC 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
G Medical Device Choke Hazard standard or guidance ISO 13485:2016 - Medical Device Quality Management Systems 2
lilybef A standard that gives requirements for medical device transportation studies? Other ISO and International Standards and European Regulations 7
A Which Standard Regulates Dirt, Fibers, Hairs, etc. on/in a Medical Device? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
D Standard Medical Device (Health) Icons? Other Medical Device and Orthopedic Related Topics 10
S Usability standard IEC 60601-1-6 in the Medical Device Industry IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
A QC (Quality Control) Visual Standard for Medical Device Product ISO 13485:2016 - Medical Device Quality Management Systems 7
T Suppliers Registered to Automotive Standard Who Manufacture Medical Device Components Supplier Quality Assurance and other Supplier Issues 4
S Mexico medical device registration - for demo Other Medical Device Regulations World-Wide 1
S EU Medical Device Regulations EU Medical Device Regulations 6
K Sample size calculation for the medical device with multiple indications. e.g. suture US Food and Drug Administration (FDA) 3
Doninina Trend Reporting for medical device class IIb according to MDR EU Medical Device Regulations 4
C Medical Device Gamma Irradiation Validation per VDmax25 (ISO 11137) Qualification and Validation (including 21 CFR Part 11) 1
S Medical device other market Medical Device and FDA Regulations and Standards News 1
Stoic Warning letter examples for medical device companies related to the pharma guidance on data integrity? US Medical Device Regulations 1
A 510(k) and DeNovo on same medical device for different indications? US Medical Device Regulations 4
I ISO13485 Folder Structuring for Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 5
S Change in material vendor - Medical device ISO 13485:2016 - Medical Device Quality Management Systems 4
I Medical Device Accessory Responsibility Other Medical Device Related Standards 7
B FDA regulations medical device prescription fulfillment DME question US Medical Device Regulations 0
J Medical Device Manufacturing Manufacturing and Related Processes 3
M An introductory guide to medical device Clinical Evaluation & Clinical Evaluation Reports (CER) EU Medical Device Regulations 0
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
E Tablet integrated into medical device IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
Ed Panek Is this a medical device? US Medical Device Regulations 2
K Medical Device file and "Component" Manufacturers? Other Medical Device and Orthopedic Related Topics 6
A Class 2b medical device - best pathway to obtain CE mark? (2022, MDR 2017/745) CE Marking (Conformité Européene) / CB Scheme 2
C Statistics/sampling plan for medical device Inspection, Prints (Drawings), Testing, Sampling and Related Topics 10
A Non-medical device testing in the medical system IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
S Training in D&D for engineers with no medical device experience Design and Development of Products and Processes 8
M Software as Medical Device import activities for Chile and Mexico Other Medical Device Regulations World-Wide 0

Similar threads

Top Bottom