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

Staff member
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

Staff member
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
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 11
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 6
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 Iraq Medical Device registration Other Medical Device Regulations World-Wide 0
R Medical Device Software Certification IEC 62304 - Medical Device Software Life Cycle Processes 1
D Medical Device Accessories Other Medical Device Regulations World-Wide 1
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
R Accelerated Aging - Creating test samples - Implantable medical device Question Other Medical Device Related Standards 4
T Clinical evaluation of a new medical device EU Medical Device Regulations 0
7 Iraq Medical Device Chemical Regulations Other Medical Device Regulations World-Wide 0
J UCLA extension Medical Device Engineering Program Training - Internal, External, Online and Distance Learning 0
Q Storing and developing SAMD (Software as a Medical Device) in the Cloud IEC 62304 - Medical Device Software Life Cycle Processes 2
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
O ANATEL certification of Medical Device Other Medical Device Regulations World-Wide 0
Ajit Basrur FDA News Harmonizing and Modernizing Regulation of Medical Device Quality Systems (7-2020) US Food and Drug Administration (FDA) 0
A Legal Manufacturer Medical device US Food and Drug Administration (FDA) 2
S Looking for Quality Content to Build Medical Device Curriculum - Concept to Commercialization Training - Internal, External, Online and Distance Learning 4
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Legal Manufacturer of a medical device Vs Legal Manufacturer of MDSW EU Medical Device Regulations 7
T Loaded spring device - Active medical device? EU Medical Device Regulations 1
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 1
A Sample Agreement available for Outsourcing Medical Device Design activity? ISO 13485:2016 - Medical Device Quality Management Systems 1
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom