QUALITY POLICY
Our commitments in detail
We are committed to offering products of the highest possible quality that comply with all relevant standards and regulations. Find out how our regulatory and quality teams ensure the compliance and safety of every product.
OUR KEY DEPARTMENTS
REGULATORY DEPARTMENT
Our regulatory department ensures that all our products comply with current European regulations, from the submission of applications through to follow-up with the relevant authorities. It works closely with the R&D, sales, marketing and quality teams to incorporate regulatory requirements right from the product design stage.
QUALITY DEPARTMENT
The Quality Department is responsible for all internal processes. It oversees the Quality Management System (QMS) and supervises inspections, analyses and batch releases to ensure that every product meets the required standards before it is distributed.
Our Activities
Our commitment to quality goes beyond mere compliance: it reflects our determination to provide safe, reliable
and high-performance products that support healthcare professionals, critical industries and end-users in their day-to-day
activities.
OUR RESOURCES & TESTS
We have an in-house laboratory equipped to carry out essential measurements:
- Filtration and respiratory resistance tests
- Material
strength tests - Measurements of basis weight,
absorbency and thickness of
materials
CERTIFICATIONS & COMPLIANCE
We comply with the following standards and regulations:
- ISO 9001:2015 – Quality Management System
- ISO 13485:2016 – Quality management systems for medical devices
- EU Regulation 2017/745 – Medical
devices - EU Regulation 2016/425 – Personal
protective
equipment
OUR QUALITY POLICY
Our approach is underpinned by a robust quality policy:
- Continuous improvement of our products and services
- Maximum customer satisfaction
- A commitment to excellence from all staff
members
OUR PRODUCTS AFFECTED BY THE REGULATIONS
Personal Protective Equipment (PPE):
Respiratory protective masks
Disposable gloves
Coveralls
Gowns
Medical Devices (MD):
Respiratory protective masks
Disposable gloves
Head covers
Footwear
Cosmetics, biocides and food contact materials:
Sleeves
Disinfection wipes
DISPOSABLE GLOVES