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Medical device manufacturer - Product certification (Small businesses)
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Medical device manufacturer - Product certification (Small businesses)
Medical device manufacturer - Product certification (Small businesses)
Medical device manufacturer - Product certification (Small businesses)
Medical device manufacturer - Product certification (Small businesses)
Medical device manufacturer - Product certification (Small businesses)
Medical device manufacturer - Product certification (Small businesses)
Medical device manufacturer - Product certification (Small businesses)
Medical device manufacturer - Product certification (Small businesses)
Medical device manufacturer - Product certification (Small businesses)
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iso 13485 - medical device qms, mdd 93/42/eec, product certification, small companies (small businesses)
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  Post Number #1  
Old 20th May 2018, 08:34 AM
bwin001

 
 
Total Posts: 9
Question Medical device manufacturer - Product certification (Small businesses)

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

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  Post Number #2  
Old 21st May 2018, 05:43 AM
chris1price

 
 
Total Posts: 245
Re: Medical device manufacturer - Product certification (Small businesses)

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
  Post Number #3  
Old 22nd May 2018, 12:42 PM
bwin001

 
 
Total Posts: 9
Re: Medical device manufacturer - Product certification (Small businesses)

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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