Manufacturer

Manufacturer

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…

We help you find solutions
We support your R&D

Our constant communication with professionals of the field has helped us notice growing necessities of their day to day lives.

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.

We work together in order to satisfy your customers

We work alongside you in simultaneous engineering, and thanks to our experience in design, we conceptualise your ideas into endless designs and solutions. We protect the solution “Intelectual property”.

Together we create new manufacturing competences

Our technological capabilities help us come up with better solutions and, at the end of the day, a better industrialisation.

We create moulds tools and manufacturing processes using highest quality materials so as to grant products of excellent resistance and durability.

We develop solutions in the different processes of Plastic (extrusion, moulding, extrusion blow moulding, injection blow moulding, micromoulding, micorextrusion, etc) and Metal (Stamping, Moulding, MIM, etc), Final Assembly and Product Finish, including Packaging and Sterilisation.

We work on OPEN INNOVATION basis – with institutions that allow us to incorporate new technological capabilities.

We certify all products (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)

  • 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.

Your New facilities in Barcelona

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

  • Manufacturing Medical Devices license number 4568-PS
  • ISO Certificate 13485:2003 (Given by UL)
  • Quality system in accordance to the European Directive 93/42 (CE) & 98/79 (CE)
  • Manufactured in clean room ISO 7 (class C, 10.000 according to GMP)
  • Packaging using a peel-pack system
  • Bar Coding GTIN (GS1 Std.), 1D (EAN 128) and 2D (Data Matrix) as to guarantee production traceability
  • Sterilisation (ETO, Gamma, Steam, etc)
  • Biological control and specific tests

You are given access to distribution leaders

We provide a broad customer base in the industry.

We help you find the best ally so you can take your products to any part of the world.