Have you Considered the Following?

Whether you are a developer and manufacturer or a distributor of Medical Devices or In Vitro Diagnostics 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?
• How do the various Medical Devices Directives affect you?
• Do you need the CE mark on your products?
• 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?
• What about the FDA GMP Regulations?
• FDA Quality System Regulation (QSR)?
• Do you need FDA 510k approval for your devices?
• How do you manage Clinical Investigations?
• 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?