Medical Devices and Cosmetics

Medical Devices and Cosmetics

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.

Environment And Waste Policy Statement

Ennogen is fully committed to ensuring that it plays its role in reducing waste and the environmental impact of our business activities. Ennogen recognises that combating Climate Change and working towards a sustainable future is a responsibility shared by all which is why we comply with applicable laws, regulations and best practices in the locations in which we operate.

Ennogen similarly encourages its partners, suppliers and contractors to adopt responsible environmental protection and waste policies in line with our values.

 

Anti-Slavery Policy Statement

Modern slavery is a crime and a violation of fundamental human rights. It takes various forms, such as slavery, servitude, forced and compulsory labour and human trafficking, all of which have in common the deprivation of a person's liberty by another in order to exploit them for personal or commercial gain. Ennogen is uncompromising in its rejection of these unethical, inhumane practices.

We are committed to acting ethically and with integrity in all our business dealings and relationships and to implementing and enforcing effective systems and controls to ensure modern slavery is not taking place anywhere in our own business or in any of our supply chains.

 

Anti-bribery and corruption Policy Statement

Ennogen policy strictly prohibits all forms of bribery and corruption. All employees are held to the highest standard in this respect and will neither accept nor offer any such inducements.

Ennogen maintains robust policies to safeguard against all such behaviour.

 

Anti-harassment and Bullying Policy Statement

Bullying and harassment, whether physical, verbal or any other manifestation of such behaviour, has no place in the workplace. Ennogen maintains a zero-tolerance policy towards bullying and or harassing behaviours.

To this end Ennogen has implemented robust prevention and remedial policies in order to cultivate a safe, inclusive and enjoyable workspace for our employees and partners.

 

Human Rights and Labour Standards Policy

Ennogen maintains the highest levels of commitment to upholding fundamental Human Rights and the maintenance of proper Labour Standards.

Ennogen seeks to provide a safe, appropriate work environment where all employees are treated with respect, dignity and consideration. This commitment is built upon a framework of policies and procedures designed to ensure fairness in the recruitment, development and retention of all employees.

 

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