Glossary

Medical devices

A medical device is a healthcare product. It is any instrument, device, apparatus or other component, used alone or in combination, including the software required to operate them. It is intended for human use in :

  • diagnose, prevent, control, treat or alleviate disease, injury or disability,
  • study, replace or modify anatomical structures or physiological processes,
  • design control.

Its primary effects on or within the human body are not achieved through pharmacological, immunological, or metabolic means, though its function may be assisted by such means. It performs its medical action through mechanical processes.

Many different products fall under this definition, including dressings, prostheses, scanners, bandages, external defibrillators, etc.

Biocompatibility (definition)

The biocompatibility of medical devices refers to a material’s ability to interact favorably with biological tissues without causing undesirable reactions.

It depends on various factors such as the duration of tissue contact, the type of interaction (e.g., direct contact or contact through body fluids), and the material’s ability to fulfill its intended function.

Physico-chemical characterization helps minimize risks by providing a thorough understanding of the material’s properties, from the manufacturing process of the medical device to its packaging and storage.

The goal is to ensure the device does not provoke toxic, inflammatory, or immunological reactions in the host organism.

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Pharmaceuticals & Veterinary

Pharmaceutical products

Pharmaceutical products refer to all items managed by pharmacists. They include a variety of products designed to improve health, whether by enabling the administration of a treatment, the application of a diagnosis, or medecine preparation.

A fundamental classification of pharmaceutical products is commonly used in pharmaceutical storage facilities (such as sales depots, wholesale distributor stores, and pharmaceutical warehouses). Pharmaceutical products are categorized into five main groups:

  • medicines
  • consumables (dressings, bandages, etc.)
  • medical equipment
  • laboratory equipment
  • miscellaneous materials

VETERINARY PRODUCTS

Veterinary products play a crucial role in preventing and controlling animal diseases. Their definition may vary by country, but the World Organisation for Animal Health (OIE) includes vaccines, veterinary drugs (such as antimicrobial agents), and diagnostic kits within its scope.

To ensure effective and sustainable disease control while minimizing risks to both humans and animals, governments must establish appropriate regulations in their veterinary legislation. These should govern the authorization, manufacture, distribution, and use of veterinary products.

PHARMACEUTICAL & VETERINARY PRODUCTS

According to article L5111-1 of the French Public Health Code, “a medicine is any substance or composition presented as having curative or preventive properties with regard to human or animal diseases, as well as any product that can be administered to humans or animals with a view to establishing a medical diagnosis or restoring, correcting or modifying their organic functions”.

Medicines come in various forms, including:

  • dry oral forms (tablets, capsules)
  • syrups
  • injectable medicines (ampoules)
  • vaccines and insulin
  • infusions
  • drugs for external use (dermatological and gynecological preparations, including local contraceptives)
  • ophthalmic drugs for external use
  • disinfectants

Chemistry

Chemistry is an experimental natural science that examins the composition of matter and its transformations. It focuses on the elements that constitute matter (atoms, ions, etc.), their properties and the chemical bonds that can form between them.

Chemistry also investigates transformations involving modifications to the external electronic layers, such as chemical reactions (oxidation-reduction, acid-base reactions, etc.) and ionization.

Chemical formulas provide a simplified way of representing molecules and are used in chemical equations.

Several disciplines in chemistry share common features but focus on different areas of study:

  • Organic chemistry (elements containing carbon)
  • analytical chemistry (identification of chemical substances)
  • biochemistry (reactions within biological systems or objects, such as cells and proteins)
  • astrochemistry (study of chemical elements in the universe)

Equipment manufacturers / Cleanroom builders

EQUIPMENT MANUFACTURER

An equipment manufacturer is a producer or dealer of electronic or electrical equipment used to outfit various areas..

CLEAN ROOM

According to ISO 14644-1, a cleanroom (also referred to as a controlled environment) is a room or series of rooms where particulate concentration is regulated to minimize contamination, generation, or retention of particles inside the space, generally for specific industrial or scientific research purposes. Additional environmental parameters such as temperature, humidity, and relative pressure are maintained at precise levels as defined in ISO 14644-1.

Cleanrooms are used in fields that require strict contamination control, including semiconductor manufacturing, biotechnology, pharmaceutical production, optical and micro-mechanical engineering, and medical research (such as the production of radioelements).

Products from BioTech / MedTech

BIOTECHNOLOGY

The OECD defines biotechnology as “the application of science and technology to living organisms and other biological and non-biological materials, for the production of knowledge, goods, and services.”

Biotechnology covers all applications of science and technology to living organisms or their components, with the aim of modifying materials—whether living or inert—to generate knowledge, products, or services.

MEDTECH

MedTech is a contraction of “medical” and “technology.” The World Health Organization (WHO) defines it as “the application of knowledge and skills in the form of devices, drugs, vaccines, procedures, and systems developed to solve health problems and improve quality of life.”

MedTech encompasses a wide range of technologies designed for healthcare environments, from online appointment booking systems to artificial organs.