Life Sciences

Using modern medicine today with ALTEN

ALTEN is an important company in the field of medical technology, which strongly supports its customers in tackling the key challenges of this industry. This includes aspects such as automation, sustainability, digitalization, e-health, and the necessary adaptations to legal regulations.

Our extensive expertise in the areas of research and development, testing and validation processes, quality management and project management, particularly about regulatory requirements, qualifies us as a reliable partner. Together with you, we build the future of this sector.

With over 35 years of experience as a provider of IT and engineering services in medical technology and an impressive history of success in international projects, which we have realized in close cooperation with well-known customers, our experts offer tailor-made solutions that are precisely adapted to your individual needs.

Market trends

Faced with new regulations, the pharmaceutical and medical device industries have an obligation to comply.

Challenges:

  • Qualify and validate the production and distribution systems impacted
  • Master the regulatory issues related to the emergence of combined products
  • Anticipate potential future requirements such as aggregation

All medical devices are potentially connectible. Some are already connected and working through applications that provide health professionals and patients with decision aids, diagnostic possibilities or automatic treatment management. There are many areas of application, including telemedicine, addiction management and chronic disease management.

Challenges:

  • Develop these embedded software in compliance with the regulatory standards of the target market
  • Prove the regulatory compliance of these products, which is complex due to the requirements related to the status of DM (Medical Device) and the presence of a software
  • Ensure personal data security and stakeholder trust

A combination product is a health product in which a drug and a medical device are combined. Similarly to an embedded software, innovation and technological progress are making this type of alliance possible more and more and here again the fields of application are numerous. One association that has become commonplace is the combination of hip replacement and antibiotics, which aims to inhibit bacterial adhesion.

Challenges:

  • Master both the normative constraints of DMs and those of drugs, to develop a registrable combined product
  • Validate the manufacturing process for these combination products
  • Be able to qualify and classify the combined product to determine the applicable regulatory status and file for registration

our clients

Pharmaceutical Industry

Medical Device Industry

Manufacturer of Wearables

ContaCt

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