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?