Our regulatory department is responsible for ensuring that the company`s products comply with the various regulations in force.

Our regulatory department works closely with the R&D, sales, marketing and quality teams to ensure that regulatory protocols are properly in place and followed and that quality and safety requirements are always met when products are launched to the market.

He ensures the filing and follow-up of regulatory files with the competent authorities.

Our quality department is responsible for all the company`s processes. In addition, it is in charge of the continuous improvement process for the Quality Management System (QMS).

This department is composed of a team responsible for controls, analyses and batch releases to ensure the conformity of products shipped the market.

The quality department has an internal laboratory equipped with technical equipment allowing various measurements of filtration, respiratory resistance, material resistance, weight, absorption capacity and material thickness.

The certifications and standards to which we comply

ISO 9001: 2015 certified, Quality management system

Certified ISO 13485: 2016, Quality management systems for medical devices

Compliance with EU Regulation 2017/745 on medical devices

Compliance with EU Regulation 2016/425 on personal protective equipment

Our quality approach

Kolmi-Hopen Group`s employees and management have established a quality policy based on the continuous improvement of the products and services the company provides to its customers.

Our objective is to achieve the highest level of customer satisfaction. This is reflected both in our ability to meet the needs of our customers and in our ability to provide them, at all times, with high quality products.

We encourage all our employees to strive for the highest level of excellence in everything they do, thus contributing to the Company`s Global Quality objectives.

Examples of products concerned by the various regulations (PPE, etc...)

Personal protective equipment (PPE) :

Respiratory half-masks
Gloves
Combinations
Blouses

Medical Devices (MD) :

Medical masks
Universal head covers, Caps
Overshoes
Care Drapes

Cosmetic products:

Impregnated washclothes

Biocides:

Disinfecting wipes

Food contact:

Disposable gloves

Kolmi Hopen Medicom Group products

Garments

Hopen - Elasticated PE Oversleeves 40 x 20 cm