Where we are

Our Roots

 

 

Since 1870 … at the Health Service
Pedro Prim Fernández, an orthopaedic surgeon and specialist in rehabilitation, founded PRIM in the late 19th century (1870). He was a pioneer who imbued his small business with his vision and work ethic. Not content to set up a prosthetics workshop, in his search for comprehensive treatment options, he went so far as to establish a spa in Alsasua (Navarra). In order to go beyond merely fitting prosthetics, he pursued his patients’ wellbeing by providing a full range of care: diagnosis, treatment and rehabilitation.
Even then, he adopted a full-service approach, focusing on quality of service and providing healthcare that was both professional and compassionate. His philosophy was a key factor that enabled the company to play an important role in the development of Spain’s medical and hospital supply industry.

 

Quality and Environmental Policy

«Innovation and quality is our company philosophy»

Innovation and quality is our company philosophy. Highly professional teams ensure continually the development and launching of new products and constant improvement in product quality and efficiency, as well as especially designed products to meet the requirements of specific customers / markets.

Our products, considered as medical devices, are manufactured according to the CEE Medical Device Directive 93/42/EEC and its update Directive 2007/47/EC.

Our operations and procedures are developed according to the requirements of ISO 13485:2016 standards.

QUALITY AND ENVIRONMENTAL POLICY 

PRIM, a company engaged in the manufacturing of orthotic and orthopaedic products, as well as in the distribution and technical service of medical devices, also committed to the manufacturing, distribution and after-sales service for rehabilitation and physiotherapy devices, declares that quality and the respect for the environment are priorities in the development of their activities, in order to meet customer needs anytime, by offering them a competitive and environmentally friendly product, by involving in these processes every company department and their personnel.

PRIM SA Quality and Environmental Management System complies with all applicable requirements described in the EN ISO 13485:2016 and EN ISO 14001:2015 standards.

The certified scope applies to:

  • Design, manufacturing and distribution of orthoses, orthopaedic devices and rehabilitation and physiotherapy equipment.
  • Distribution and technical support of medical and non medical devices.
  • Grouping of CE marked medical devices for procedure packs.

The guidelines and general objectives related to quality assurance and environmental management, to which PRIM is committed to, are unified and described in their Quality and Environmental Policy Statement, which is defined by Head Direction as part of the general policy of the company and consistent with it.

Our Quality and Environmental Management guidelines are:

  • Commitment to meet the requirements of the interested parties and maintain the efficiency of both QR and EM systems.
  • Make sure that the products and services provided to the customers are safe, reliable and meet all the specifications, standards and codes which apply to them.
  • Work and collaborate closely with customers in the improvement of our products and services.
  • Settle actions and programs not only focused on the detection and correction of non-conformities but aimed at prevention
  • Measure and analyse all the data related to Quality and Environment processes in order to attain and maintain a continuous improvement in the organization.
  • Commitment to the products marketed and developed for the prevention of Pollution at all stages of the process and respect for the environment. Commitment from the entire organization with pollution prevention and environmental protection.
  • Comply with the applicable statutory and regulative requirements related to service and sales, and also with the specific relevant to the context of the organisation and stakeholders.
  • Develop projects in order to improve our products and services, from a technological, environmental and quality point of view.
  • Educate, motivate and involve the entire staff working on behalf the company in the management and development of the implemented Environmental and Quality Management System.

In order to implement these quality and environmental management objectives, PRIM carry out their management based on the following standards and directives:

  • Council Directive 93/42 EEC concerning medical devices.
  • EN-ISO 13485:2016. Medical devices. Quality Management Systems Requirements for regulatory purposes.
  • EN ISO 14001:2015. Environmental management Systems. Requirements with guidance for use.

This statement will be reviewed every year and will be updated whenever the changes require a new document.

This statement provides the framework to settle and review the environmental objectives and targets of this management system and it’s appropriate to the purpose and context of the organization.

This Policy will be made available to interested parties by defining the channels of communication.

PRIM’s Management shows its engagement by means of this statement and takes responsibility for its understanding, implementation and continuous updating at every level of the company.

(*)Document excerpted from PRIM Quality Manual, 18th revision Abril 2019, paragraph 5.3.

      

 

Factory

Our Factory currently occupies facilities of over 6.000 m2 in Móstoles (on the outskirts of Madrid) and it has been conceived as a compact Development & Production Unit. This integration gives our production high efficiency in all processes, from conception of the idea to its placing on the market. Our strict Quality Policy is the final link in the chain to ensure that our products reach the market in the best condition. So that all our products are manufactured accordingly with the CEE Medical Device Directive 93/42/EC and its updated Directive 2007/47/EC with the requirements of ISO 13485:2003 standars. In that way, we produce more than 3.000 different items that are distributed both domestically and in foreign markets. This plant focuses its activity on Orthotics product lines with specialized units for the treatment of textiles, plastic and metal.

Following that front line, in the last two years there has been a strong commitment towards technological renovation in order to achieve higher added value products and improved production flexibility. To that end we have added new units for High Frequency sealing of textile products, we have significantly increased our stock of automatic sewing machines as well as die cutting and Velcro-cutter machines and we have incorporated a new automatic cutting machine with Cad-Cam reader system. And we are still planning new investment projects for continuous improvement of our products that will be released in the coming months.

Prim also has a second production facility in Casarrubios del Monte (Toledo) for the development and manufacture of silicone product line, focused primarily on the Foot Care market. We have 3.500 m2, including manufacturing  facilities and warehouse that accommodate the most advanced technology in the sector allowing us to produce under the same standards that we apply to our center of Mostoles. As is the case with our Orthotics products, silicone products are distributed both in the Spanish market and internationally. The warehouse serves to the whole group.

«Continuous improvement processes in manufacturing»

Who is Prim Ortopedia

 

«Prim Ortopedia develops, manufactures and distributes orthopaedic products and daily living aids»
Prim Ortopedia develops, manufactures and distributes orthopaedic products and daily living aids trought orthopaedic supply shops, pharmacies and pharmacie dealers.

This includes an extensive range of orthotics such as ankle and knee support, girdles, wristbands, hyperextension braces, etc., as well as prostheses and prosthetic components, daily living aids, incontinence and electromedical products.

Prim sells products manufactured in-house under well-known brands such as PRIM, ORTHOPRIM, CAMP, ELCROSS, BEBAX, SWASH, TOPLINE, CONFORSIL, in Spain, and in other countries.
We also distribute other lines of orthopaedic products from leading international companies.

 

Contact