ALN Implants chirurgicaux

Our quality commitments at every level

Our company ALN, a French manufacturer of high-tech medical devices for the prevention of pulmonary embolism, has always had the main objective of saving lives all over the world. Our responsibility is great and we are fully aware of it. The importance given to every detail, every gesture, every decision is a top priority for ALN. This has been our approach since our creation, more than 30 years ago.

From our Research and Development department to our manufacturing workshops and - our quality department, our commercial, distribution and shipping units... We apply the same rigour and attention to detail.

Our performance is recognized in France, but also in Europe and around the world, and this is no accident. 

The trust of our customers is at the heart of our essentials, supporting our commitment to shape quality medical devices.

 

A high level of expectation for optimal quality and client satisfaction 

Since its creation, ALN surgical implants has been committed to a quality management approach, in order to reach an optimal level of quality for all our products and thus be able to fully meet the needs of our customers, in France, as in the rest of the world. 

 

The very organization of our company is based on a quality management system based on

 
continuous improvement of our products and processes
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proactive listening to our customers' expectations and needs, to provide useful, efficient and targeted responses

Our quality commitments at every level

Continuous, controlled and reliable quality

As a manufacturer of vena cava filters and removal and/or repositioning kits, we must comply with the legal, regulatory and regulatory requirements that apply to our activities and products. A central commitment that is at the heart of our quality policy.

 

  • A quality policy organized into 3 major commitments

    • Comply systematically and fully with the various applicable regulatory and regulatory requirements (ISO 13485, Directive 93/42/EEC, Regulation (EU) 2017/745, Public Health Code, 21 CFR Part 820 and other foreign regulations related to the countries where our products are marketed).
    • Concretely implement and deploy a specific and proven quality process, focused on the continuous progress of our products and practices.
    • Constantly building trust and customer satisfaction


  • Regular and careful audits and quality checks, verified effectiveness

    Each year, during the management review, we carry out a review of the previous year, during which the effectiveness of the quality management system implemented is checked with the greatest attention. Strong attention is then paid to the relevance, adequacy and effectiveness of this. 

    The quality objectives are set by our management and are consistent with our company’s strategy and quality policy.

    Our Quality and Regulatory Engineer is mandated each year to :

    • Ensure that the quality policy is applied rigorously and consistently
    • effectively implement and maintain the quality management system
    • Ensure compliance with legal, regulatory and regulatory requirements related to our products and activities

     

    It should be noted that, of course, we are also committed to ensuring that the necessary and indispensable resources for the achievement of these quality objectives and the maintenance of a compliant and effective quality management system are available and accessible.

Our employees are together committed to quality

For our company ALN implants chirurgicaux it is crucial that all of our employees adhere with intention, sincerity and commitment to our quality policy.

At ALN we work together with the same goal: to save lives. Teamwork must involve each and every one of us at all times, because a company is like the life we defend, always on the move… A movement that translates into rules defined, understood, and of course applied by all.


All of our employees must pay their attention and be constantly committed to respect and embody four core values that we strongly advocate:

  • Quality of work and products, the cornerstone of our success.
  • Responsiveness, which makes us constantly listen to our customers.
  • Work and product performance, which must continuously improve.
  • The rigor of quality and efficiency that is our hallmark.
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