Hello!
We are a manufacturer of class I and class IIa devices who currently holds ISO 13485:2016 certification. We are a small company (30 employees) and we are certainly feeling the burden of increasing regulatory demands (EU MDR, Brexit changes to UK regulations, MDSAP etc). We recently had to give up our efforts to gain MDSAP certification due to the cost and resource involved. Without the Canadian market our class IIa sales are not necessarily justifying the regulatory expense. It has got me thinking about whether, if we dropped the class IIa products and only sold class I devices whether keeping our 13485 certification (and the hassle/cost of annual audits) is worthwhile? I wondered if anybody had been faced with this dilemma before and what the pros and cons are. I understand that the EU MDR requires that the manufacturer has a QMS but does not specify 13485.
We do sell our class I devices all over the world and I know ISO 13485 is valuable to aid registration in other countries, as well as when we are manufacturing for others. Are there any countries that require 13485 for registration of class I devices?
I would welcome any insight
We are a manufacturer of class I and class IIa devices who currently holds ISO 13485:2016 certification. We are a small company (30 employees) and we are certainly feeling the burden of increasing regulatory demands (EU MDR, Brexit changes to UK regulations, MDSAP etc). We recently had to give up our efforts to gain MDSAP certification due to the cost and resource involved. Without the Canadian market our class IIa sales are not necessarily justifying the regulatory expense. It has got me thinking about whether, if we dropped the class IIa products and only sold class I devices whether keeping our 13485 certification (and the hassle/cost of annual audits) is worthwhile? I wondered if anybody had been faced with this dilemma before and what the pros and cons are. I understand that the EU MDR requires that the manufacturer has a QMS but does not specify 13485.
We do sell our class I devices all over the world and I know ISO 13485 is valuable to aid registration in other countries, as well as when we are manufacturing for others. Are there any countries that require 13485 for registration of class I devices?
I would welcome any insight