MDR imposes high demands on manufacturers and products
The EU Medical Device Regulation (MDR) places high demands on manufacturers and products. All products placed on the market must be secure and deliver on their promises.
We are certified to ISO 13485, which means that our quality management system is specifically tailored for developing, manufacturing and handling medical devices.
This certification ensures that our processes meet the relevant regulatory requirements and support compliance with the MDR, whilst contributing to a high and consistent standard of quality in everything we do.
Safe products that keep their promises
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Extract from our quality policy
We work for strong and long-lasting customer relationships
Customers should experience:
A high product quality
A good support and guidance
A high delivery accuracy
A great professional knowledge
By constantly developing and improving our products and services and adapting them to our customers' needs, Multilens will maintain and strengthen the confidence of our customers.
All our employees have, and are aware of, their personal responsibility for producing the right quality and together we take overall responsibility for our deliveries.
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ISO 13485:2016
"This is to certify that Multilens AB holds certificate number: MD 763875 and operates a Quality Management System which complies with the requirements of ISO 13485:16 for the following scope: Design, manufacturing and distribution of sterile soft contact lenses, non-sterile rigid gas permeable lenses, spectacle lenses, spectacle frames and accessories for spectacles, and distribution of contact lens accessories."
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Sustainability
For us, sustainability encompasses the environment, the workplace, and the stability of long-term business operations. Our CSR initiatives are aligned with Agenda 2030 and the UN's Global sustainability goals, with a specific focus on areas related to health, production, and overall sustainability.
MDR-certificate
Declaration of Conformity - Soft Contact lenses
Declaration of Conformity - Rigid Contact lenses
Declaration of Conformity - Rigid Trial Lenses
Declaration of Conformity - ML Filter
Declaration of Conformity - Spectacle lenses
Declaration of Conformity - Ready ro wear spectacles
Declaration of Conformity - System Solutions
Declaration of Conformity - Spectacle frames
Certificate of Registration