Medical device manufacturer - Product certification (Small businesses)

#1
Would you advise a small business owner to have their product certified after the 93/42 ewg? Is ISO 13485 mandatory or not? Is it even possible to do it without much prior knowledge?

Thank you in advance for the answers:bigwave:
 
#2
Hi, I'll try to answer your questions:

Would you advise a small business owner to have their product certified after the 93/42 ewg? - if you want to sell a medical device in Europe today, it must be CE Marked according to 93/42/EC today. Going forward, the MD Regulation will take over.

Is ISO 13485 mandatory or not? - No it is not mandatory, however you must have a quality system. The extent of the Quality System depends on the product, its classification and the chosen conformity route.

Is it even possible to do it without much prior knowledge? - Unfortunately, it will be difficult without prior knowledge, either within your company or by using a consultant.

Chris
 
#3
Hello Chris,

Thank you for your answer, so it will probably be expensive without much knowledge or right?
maybe you have an idea if it is for the 60601-1 standard, somewhere here in the forum a summary?
 

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