Consulting: Conformity Assessment
The Medical Device Directives (MDD93/42/EEC; AIMDD 90/385/EEC; IVDD 98/79/EC) require the manufacturer of those products to implement a conformity assessment procedure which must be applied to his products.
For higher risk class products a Notified Body may be involved. MDSS will guide you through this process successfully. MDSS specializes in the product classification. Please contact us for further details and how MDSS may best support you.
For higher risk class products a Notified Body may be involved. MDSS will guide you through this process successfully. MDSS specializes in the product classification. Please contact us for further details and how MDSS may best support you.
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According to the Directives:
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93/42/EEC (MDD)
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98/79/EC (IVDD)
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90/385/EEC (AIMDD)
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Product Classification
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Correspondence with Notified Bodies and Competent Authorities
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