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Medical Safety Testing

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As a Notified Body (No. 0470) within the EU/EEA for Medical Devices Directive (MDD) 2007/47/EC (amending 93/42/EEC), we can cover your compliance needs for product requirements (IEC 60601 series) as well as Quality Management System (ISO 13485) requirements.

Nemko has extensive experience testing many kinds of medical products according to:

  • EN/IEC 60601-1 (General requirements for safety)
  • EN/IEC 60601-1-xx (Collateral)
  • EN/IEC 60601-2-xx (Particular) series of standards
  • With over 50 part 2 (Particular) standards, Nemko can assist you to ensure your product complies.

Nemko is accredited according to EN 45011 (ISO/IEC Guide 65) and ISO/IEC 17025.

  • Medical Devices Directive, Class I-m (measuring), I-s (sterile), IIa, IIb, III
  • EC Declaration of Conformity; compiling of test reports and required documentation for the technical file (MDD Annex VII).
  • EC Type Examination Certificate (MDD Annex III).
  • Full Quality Assurance with reference to EN ISO 13485 (MDD Annex II).
  • Production Quality Assurance with reference to EN ISO 13485 (MDD Annex V).
  • Product Quality Assurance with reference to MDD Annex VI.
  • EC Verification MDD Annex IV.
Contact us for information or a quote: 

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