Distributor

Distributor

We design, manufacture and market small and/or big volumes of products, components or assembling, packaging and/or sterilization services

We cover each and every necessity of your project in all the stages of the value chain

Together, we analyse your needs and create innovative solutions

Our Value Proposition…

Our relations with the innovation department

Our constant communication with professionals of the field has helped us notice growing necessities of their day to day lives. From the creation of small solutions to its clinical test that bring added value and the design of innovative solutions that are being developed and are not, yet, in the market.

We invest in R&D

Working alongside reference hospitals and their teams of professionals, in a variety of fields, we carry out the creation of new and improved medical solutions.

Our capabilities keep growing

In each and every project, we use highest quality materials to create moulds tools and manufacturing processes so as to grant products of great resistance and durability.

We can be your fine print (CE)

Our experience in international regulatory processes is our biggest quality warranty.
We certify, homologate and manage the whole regulatory process of your products.
(Directive 93/42 & 98/79 and Regulation 745/2017 & 746/2017)

  • Prepare the introduction required for the marketing authorisation application.
  • Preparation of Technical Files to show in EU and non-EU countries.
  • During the elaboration of the Technical File, design documentation and risk managing are done following the ISO 14971 criteria, covering areas such as sterilisation, controlled production environment, clinic evaluation and essential requirement analysis.
  • Regulatory support from the presentation of the register to the authorisation of the product by answering the allegations required for different regulatory authorities, including post-authorisation regulatory works, such as applying for changes or re-validations.

We manufacture in Barcelona,
European capital of Innovation.

We own high tech facilities, capable of doing any kind of productive process in conformance to the market needs.

Small and/or big amounts of products, components or assembling services such as packaging and/or sterilization.

We are your pipeline

We provide a wide variety of products, all of which have been the result of our devotion and passion for innovation. We strive to make our customer list grow – in the distribution field: experienced experts, big and small companies, etc., but we want all of them to share the same goal – to be a reference to our standards of quality.