Kwaliteit - Hubert De Backer nv

Quality

Quality: our pet peeve

At HDB, we strive to deliver plastic products of outstanding quality. To achieve this, we keep our molds and machines in perfect working order, validate our production processes, and perform extensive inspections on all our products. This ensures that the dimensions, functionality, and visual appearance of our products meet our high standards. We know who we make our products for: someone’s child, loved one, or pet. And they deserve only the very best.

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Keeping pace with international standards

For over 30 years, we have been fully focused on the pharmaceutical and medical device industries. Our quality system is fully tailored to this. We work in accordance with ISO 9001:2015 (standard for quality management systems), ISO 15378:2017 (standard for primary packaging materials of pharmaceuticals), and ISO 13485:2016 (standard for medical devices) and hold the corresponding certifications for each of these standards. We also market medical devices under our own name, which comply with European and British legislation (CE and UKCA marking).

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Pure and safe products

Thanks to our years of experience in the industry, we know that our customers have high expectations for the cleanliness and hygiene of their products. To meet these demands, we have a nearly 4,000 m² cleanroom (ISO 7). Furthermore, we can arrange gamma and X-ray irradiation upon request, to deliver products of the highest purity to our customers. The necessary certificates and supporting documentation confirm to our customers that the materials used are safe for use.

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Follow up and adjust

A system of procedures, internal inspections, calibrations, conformity assessments, and corrective and preventive actions ensures we maintain our high quality standards. We are also happy to accommodate specific customer requests and document these in a quality agreement. Our quality department is available daily to handle customer questions and feedback.

Our certificates

ISO 9001:2015

Quality management

system

Download the certificate

ISO 15378:2017

Primary packaging materials

for medicinal products

Download the certificate

ISO 13485:2016

Medical devices

 

Download the certificate

ISO 14001:2015

Environmental management
system

Download the certificate

EU MDR

Medical Device

Regulation (EU) 2017/745

Download the certificate

UK MDR

The Medical Devices

Regulations 2002

Download the certificate

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