Quality & Feedback

We take quality seriously and therefore we take customer feedback very seriously. In case you have anything to share with us, a complaint, a suggestion or a compliment, please contact our quality manager Mrs Denise Dam.

Your feedback gives us the opportunity to provide you with an adequate respons and to learn from existing products and improve future products.

Clean Manufacturing

Our manufacturing complies to ISO 5 and ISO 7 / grade C cleanroom standards, following Annex 1 of the (European) standards on GMP manufacturing, "Manufacturing of Sterile Medicinal Products"

ISO13485:2016

To demonstrate quality, as of 2015 we have adopted a full scope management system to comply to ISO13485 with the following Scope: Design & Development, Manufacturing and Distribution of silicon microneedles for intradermal use, as certified for compliance by our notified body, DEKRA. We are currently changing to ISO13485:2016.

CE & Full QA System

We have also implemented the full quality assurance system for the product category silicon microneedles for intradermal use, to be able to design and develop innovative intradermic needle designs in-house. As DEKRA stated in her Certification Notice:

For the product category Silicon microneedle for intradermal use DEKRA grants the right to use the EC Notified Body Identification Number 0344 to accompany the CE Marking of Conformity on the products concerned conforming to the required Technical Documentation and meeting the provisions of the EC-Directive 93/42/EEC on Medical devices, Annex II excluding (4), being Devices in Class IIa, IIb or III

DEKRA hereby declares that Manufacturer U-Needle fulfils the relevant provisions of 'Besluit Medische Hulpmiddelen', the Dutch transposition of the Council Directive 93/42/EEC of June 14, 1993 concerning Medical devices, including all subsequent amendments. The manufacturer has implemented a quality assurance system for design, manufacture and final inspection for the above mentioned product category in accordance to the provisions of Annex II of Council Directive 93/42/EEC of June 14, 1993 and is subject to periodical surveillance

Certificates | Statements

Please don't hesitate to contact the quality department directly in case you require a copy of our certificates or statements, that you might require as input for your clinical investigations or supplier selection process