Safety Requirements

Regen Lab SA is a pharmaceutical and medical devices manufacturer authorized by swissmedic (the Swiss agency for the authorisation and supervision of therapeutic products).

The company is manufacturing medical devices class IIb or Class III for human use under the certification of the notified authority and in compliance with (Law / Norm):

• EC 93/42, essential requirements for medical devices
• ISO 9001-2007, Company management systems
• ISO 13485-2003, Medical devices management
• ISO 14971, Safety of Medical devices
• ISO 11600, Conditioning of Medical devices etc.

Following the International Conference of Harmonisation (ICH) in force since January 2003, signed by all countries, the same laws and regulatory requirements applies worldwide.