Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body

#1
Greetings all,

I am a Quality Assurance / Regulatory Affairs Manager at a Start-up in California. We are trying to get an ISO 13485 audit scheduled with BSI as well as a Technical File (or Documentation) review some time this year. Unfortunately they are refusing new customers. They don't want to perform stand-alone audits, as they no longer do MDD Technical File reviews, and are not legally allowed to schedule for MDR Technical Documentation reviews.

Is anyone having similar experience and do you have any recommendations?

I have already started contacting some backup registrars / notified bodies, but I am seeing a lot of the same issues. (TUV SUD, TUV Rheinland)

Matthew
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
Yeah, you're in a weird place. On one hand, it's good BSI refused, knowing that they don't have resources to support you. Reviews across the board are taking a very long time (so it's not just BSI that's swamped).

The only recommendation is to keep looking for a NB that will take you on. Be sure they are accredited and plan to at least file for designation under the MDR.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
Unfortunately they are refusing new customers.
Welcome to The Cove. This issue has been discussed a number of times here. In most cases, the most well known ISO 13485 CB's are also Notified Bodies for Medical Devices. These organizations are under severe pressure from the competent authorities and subjected to increased oversight. Most of them are scrambling for resources and your situation is not unique.

It seems to me that, due to some high profile ethical breaches, the French PIP scandal being one of the most public ones, many CB's/NB's are uncertain about the legal risks they face and don't want to expand their business much bigger than what they have now. A multi-billion dollar/euro penalty would wipe out any of these organizations.

Good luck.
 

mihzago

Trusted Information Resource
#4
BSI is not being very responsive. I've been asking them to schedule MDSAP audit for two years now to no avail.
Someone recently had luck with Intertek so you could try them.
 
#5
Thank you for the feedback. In talking to the notified bodies I have heard nothing but bad things about MDSAP. At my previous company we went through an MDSAP audit and it was a nightmare. 8 months after the audit still waiting for them to formerly close the audit and give us the certification. I can understand if the notified bodies don't want to perform MDSAP anymore.
 
#6
Greetings all,

I am a Quality Assurance / Regulatory Affairs Manager at a Start-up in California. We are trying to get an ISO 13485 audit scheduled with BSI as well as a Technical File (or Documentation) review some time this year. Unfortunately they are refusing new customers. They don't want to perform stand-alone audits, as they no longer do MDD Technical File reviews, and are not legally allowed to schedule for MDR Technical Documentation reviews.

Is anyone having similar experience and do you have any recommendations?

I have already started contacting some backup registrars / notified bodies, but I am seeing a lot of the same issues. (TUV SUD, TUV Rheinland)

Matthew
Hi Matthew,

since you mentioned that you are contacting some backup notified bodies, maybe you want to try with ECM?
I was recently approached by their Account Manager on LinkedIn, he was promoting their services and mentioned that they are open to new customers. My company doesn't need it, but it might help someone else.
I checked, ECM (no. 1282) is both the NB for CE marking as well as ISO 13485 certification body.
 

PearlKetchup

Starting to get Involved
#7
My (startup) company uses LNE/G-MED and I've enjoyed working with them so far. You might try reaching out to them? My company had been customer for a few years before I joined so a good working relationship has already been established. It seems that they are handling the MDD/MDR transition well and from my interactions with our project manager there I recommend them.
 
Thread starter Similar threads Forum Replies Date
W My company is looking to start a materials testing lab that conforms to ISO17025:2017 ISO 17025 related Discussions 3
M AS9100 - Where to start - Small company (10 employees) and I am the Quality Dept. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 45
M How do you start a calibration/anything company? Career and Occupation Discussions 11
B Gap analysis of new start-up company technical documentation CE Marking (Conformité Européene) / CB Scheme 1
P CA,PA, Continual Improvement - How to start in a Service Company Quality Tools, Improvement and Analysis 1
A How best to start revising an existing ISO 9001:2008 system in a company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K How to start a Design History File (DHF) for Medical devices Company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Start from Scratch: How to get my company ISO 13485 certified ISO 13485:2016 - Medical Device Quality Management Systems 11
S Start Up of Department in a new Medical Device Company Other Medical Device Regulations World-Wide 6
S Can certification be achieved for a start up company before trading? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
C Suggestion for Implementing ISO 9001 in a Start-Up Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
O Developing a QMS for biomedical start up company which only does R&D? ISO 13485:2016 - Medical Device Quality Management Systems 5
J Start Up Medical Device Company - As a device company what FDA cert do we need? ISO 13485:2016 - Medical Device Quality Management Systems 5
A My Company wants to Implement ISO 9001-2000 and become Certified - The Big Start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M Pharmaceutical Non conformances SOP - Solid oral dose start up company Nonconformance and Corrective Action 2
R New to ISO9001 - Implementing ISO 9001 at company - Resources and where to start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
G Choosing a Sampling plan for Start Up Fabless IC Company - Guarantee a 200 DPM limit Inspection, Prints (Drawings), Testing, Sampling and Related Topics 9
D Choosing a notified body for a new start up company in the UK - Medical Device area Registrars and Notified Bodies 6
G When to start calibration cycle - Electronic test equipment rental company General Measurement Device and Calibration Topics 3
V How can I start explaining and training SPC in my company? Statistical Analysis Tools, Techniques and SPC 6
A Implementing ISO 9001:2000 - Service Company - Where do I start? Service Industry Specific Topics 9
A ISO 9001 Registration for Start-up Company - So Many Questions... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
U Examples of Quality Objectives for a Medtech start up ISO 13485:2016 - Medical Device Quality Management Systems 4
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
A AS9100 Training - Where do I start? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
mike10 QMS Update - Rev. up or start over? Document Control Systems, Procedures, Forms and Templates 2
N China - Start manufacturing before change approval? China Medical Device Regulations 1
S How to start with ISO process in project based team - Documentation Document Control Systems, Procedures, Forms and Templates 4
A Implementing ISO 20000-1 - Where to start Other ISO and International Standards and European Regulations 2
T CE mark start date for a device EU Medical Device Regulations 7
qualprod Statistics - Where to start in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
G Start and main steps of API Q1 Certification Process Various Other Specifications, Standards, and related Requirements 5
M Error trying to Start a New Thread Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 2
H Transferring an ISO 13485 certificate to a new CB - Do I have to start from scratch? ISO 13485:2016 - Medical Device Quality Management Systems 2
Marc Basic - How to Start a New Discussion Thread Elsmar Xenforo Forum Software Instructions and Help 1
TheMightyWife Can not start Personal Conversations Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 18
E Is it possible to start an ISO 9001 QMS from scratch (Really) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
E ISO 9001 certification of the new plant before start of production ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
qualprod How to start with Lean? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
R QMS and ISO - Where to start? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
S ISO 17025 - Help in Getting accreditation- Where to start from ISO 17025 related Discussions 12
H Need to Start an R&D Laboratory, what to do? Design and Development of Products and Processes 6
O Start Up Approval Dimension Records IATF 16949 - Automotive Quality Systems Standard 5
V Product Development - When to start calculating Process Capability Capability, Accuracy and Stability - Processes, Machines, etc. 3
Moncia Design FMEA - Where to Start FMEA and Control Plans 20
M Where does Document Revision Control Start? Rev 0 or Rev 1 Document Control Systems, Procedures, Forms and Templates 19
M How to Start SPC from the ground up! Statistical Analysis Tools, Techniques and SPC 8
A Start Up of a small AS9100 Machine Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Where to start to helping other companies to get ISO IEC 27000? Consultants and Consulting 1
M APQP and PPAP for Beginners - Where do I start? APQP and PPAP 48

Similar threads

Top Bottom