Ennogen operates a Quality Management System which complies with the requirements of ISO 13485:2016
EN1SO 13485:2016 for the following scope:
Control of manufacture and distribution of vapo-coolant and cryo-analgesic sprays. Design and control of the manufacture of wound irrigation solutions.
Devices:
Ennogen Holds EC certificate-Full Quality Assurance System in respect of Design and control of the manufacture of wound irrigation solution. Ennogen Quality Assurance System meets the requirements of Medical Device Directive 93/42/EEC annex II excluding section 4 with regards to this device. Ennogen Holds EC certificate- Production Quality Assurance in respect of manufacture of vapo-coolant and cryo-analgesic sprays. Ennogen Quality Assurance system meets the requirements of the Medical Device directive 9/42/EEC annex V with regards to this product.
Ennogen holds registration for placing on market non medicated emollient creams/ointments (class I medical devices) with the UK regulatory agency the MHRA. Ennogen is involved in developing new medical devices– from identifying new ideas to product development in compliance with standards and guidelines.








