Does anyone has feedback on a notified body for small companies?

[happylola]

Hello.
We are looking for a notified body to CE Mark our Medical Device. Some of them have a one size fits all policy and require highly expensive payments. Has anyone worked with a notified body that tailors the financial proposal to the size of the company and can share the name and some feedback?

 

[Ed Panek]

We are small <25 employees. You will experience lower fees as the audit durations are typically based on number of employees. There are no other savings I think to be had.

Now that MDR is in effect the costs will only rise as NB have to increase the size and competence of their staff.

 

[Raisin picker]

Can you tell me a store that sells new apple computers with price tags according to personal income?
A small company often is more effort for the NB (noone in regulatory who understands MDR, especially the clinical part), and at the moment, NBs are flooded with requests for quotes. So why should they offer their work below market value just because you are small?
Please don't take this personal, it's just to show that your request might not yield the answer you want. There are NBs that cater for larger companies, and those that focus on smaller companies. They all have to show the price tag on their web page (MDR requirement), so you should be able to compare, but do not expect to get any discount whatsoever. And good luck finding one that currently takes new customers.
What Ed says is true, there is some regulation out to that respect. Audit time is based on company size (and a variety of other factors). And audit costs vary of course based on the travel expenses.

 

[Jhunt]

I have worked with multiple companies that have obtained certification through multiple registrars. I have found that some registrars will interpret the standards in a way that maximizes their profit potential. Some registrars hold a medical device company to pharmaceutical standards. Some registrars work as your partner helping you to maintain compliance while others will lay down their rules and threaten you in every communication with the loss of your certification. In all my experience in big and small companies I have found that Intertek has been the best to work with to obtain and maintain certification. They clearly cite the applicable regulatory requirement for every finding. One company I worked with would cite a general clause and state that it was their interpretation. Intertek also doesn't have special audit finding closing meetings that are at least an additional 1/2 of auditing charges in order to close out findings which you have to schedule once the CAPA is closed in your system. I know that a small company does not have the financial or personnel resources of a large company and it is not economically feasible for them to have to support the unnecessary burden of excessive auditing which goes beyond the requirements of the standards. Also, the constant threat of losing certification if you don't do exactly as they think you should can be extremely stressful as it could cause a company to close. Why a registrar would make it a practice to overburden a company and use fear of retribution to keep them from protesting is beyond me. I encourage any company that is in fear of their registrar to investigate alternatives. But don't let them know or you will be hit with enough majors and threats to keep you in a state that you cannot switch. You cannot change registrars if you have open major findings.