What are you laughing at?
There is very little to laugh at, as since 2017, eyewere manufacturers and distributors must comply with the requirements of the Medical Device Regulation.
Clariscience can help you complying with the requirements of the Medical Device Regulation in several ways:
If you are a Manufacturer
- verifying that the technical documentation of the glasses you produce is adequate: arranging it on your behalf or giving you the appropriate suggestions so that you can do it on your own
- evaluating the adequacy of your Quality Management System (through remote audits or in presence at your facilities) and checking your Manual, your Procedures and how you keep records, again intervening directly or enabling you to be autonomous in their accommodation also through targeted training activities
If you are a Distributor
- verifying, together with you, that your system really allows your organisation to meet the new obligations, helping you to implement the appropriate corrective actions, if necessary, and training the staff involved in daily operations
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