Issues to Consider

Have you Considered the Following?

Whether you are a developer and manufacturer or a distributor you need to keep abreast of the myriad legislative measures which affect the industries.

  • Do you need ISO 9001 and ISO 13485 registration?
  • How do you apply EU Harmonised Standards?
  • Is involvement with a Notified Body required?
  • Is verification and validation required for your devices and for software?
  • Are you up to date with process and equipment verification and validation?
  • How do you control Product Development?
  • Do you have an Authorised Representative in the EU?
  • Do your products require electrical safety testing?
  • Are your devices affected by the EMC and low voltage Directives?

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