Kolmi Hopen Medicom Group
Kolmi Hopen, French manufacturer for over 50 years. Kolmi Hopen Group (Medicom Group) is a leading actor for more 40 years in conception, manufacturing and business of single use products. The group offer, composed by innovative products, is dedicated to 4 fields of activity : medical, dental, industry and hygiene. First of all, as a mask manufacturing leader, then Kolmi Hopen Group expand activities to shoe covers, gloves, garments, disinfection products and others, for professionals.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Internationally (various countries)
This company also provides solutions for other industrial applications.
Please, visit the following links for more info:
About Us
Kolmi Hopen, European heart of the Medicom Group
The Kolmi Hopen Group has been the French leader in single-use protection for over 50 years.
It designs and manufactures products with exclusive technologies for contamination control and risk prevention.
We are part of Medicom, a Canadian group with a worldwide reputation for providing protective solutions for the dental, medical and industrial sectors.
We are a European company specialised in contamination control and risk prevention solutions, and are committed to delivering excellence to our customers.
We strive to create partnerships with our customers through lasting relationships, by offering high-quality high-added-value products supported by exceptional service based on continual process improvement.
We foster a work environment that brings out the best in every employee.
We are dedicated to the continual improvement of solutions for the medical, industrial and hygiene markets.
Our goal is to provide distributors, professionals and end users with the most reliable brand of products offering exceptional value.
We bring an entrepreneurial passion to everything we do to offer customers an unparalleled experience.
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Responsibility
We design highly engineered products that need to meet the current requirements of standards and regulations. -
Local support
We provide local support to our customers and users, from the design to the use of our products. -
Confidence
We give our users the confidence they need while they face risks, as they know they can rely on our products.
Quality Commitment
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