Inside our laboratory
Research, expertise
and news.
News from Vitrobio and the topics driving our laboratory forward.
Private-label medical devices: how to choose a manufacturer
Choosing a private-label medical device manufacturer means aligning a market need, a documented product and a distribution organisation. Here are the points to consider before building your range.
MDR and private label: which documents should you review before a partnership?
Before marketing a medical device under your brand, link each document to a specific product and market. Private label describes a commercial offering; it does not, by itself, define regulatory responsibilities.
Medical devices with local physical action: understanding the principle
Local physical action takes place at the application site. Three concepts help explain VITROBIO technology: the surface film, fluid exchanges through osmosis and the role of polymers in the formulation.
Colds and allergic rhinitis: what is the difference?
A runny or blocked nose can occur with both a cold and allergic rhinitis. The cause, circumstances of onset and associated signs help distinguish them, but cannot establish a diagnosis on their own.
Understanding the Physiopathology of Pressure Sores: Causes, Prevention, and Treatment
Pressure sores, also known as bedsores or pressure ulcers, are injuries to the skin and underlying tissue resulting from prolonged pressure on the skin. These sores often develop on skin that covers bony areas of the body, such as heels, ankles, hips, and tailbone. For individuals with limited…
Decoding asthma: understanding its causes and symptoms
Asthma is a multifactorial disease, meaning it can be triggered by a variety of factors. Understanding what sets off an asthma attack is crucial for managing the condition effectively.
Understanding Rhinosinusitis: Pathophysiology and Key Insights
Rhinosinusitis is a condition characterized by inflammation of the nasal passages and sinuses. This inflammation can lead to a range of symptoms that impact your daily life, from mild discomfort to severe pain and congestion. Understanding this condition involves delving into its causes, symptoms,…
Understanding the Pathophysiology of Eczema: Causes, Symptoms, and Treatment
Understanding the root causes of eczema can be as complex as the condition itself. Eczema, also known as atopic dermatitis, is not triggered by a single factor. Instead, it results from a combination of genetic, environmental, and immunological elements.
Understanding Hemorrhoids: A Deep Dive into Their Pathophysiology
Hemorrhoids are essentially the swollen and inflamed veins found in your anus and lower rectum, bearing a strong resemblance to varicose veins. They often result in discomfort and can manifest in several uncomfortable symptoms, such as pain, itching, and bleeding. These symptoms are indicative of…
Understanding Migraine Pathophysiology: Causes, Symptoms, and Treatment Options
Understanding the triggers of migraines is crucial for managing and potentially preventing these debilitating episodes. Migraines can be set off by a complex interplay of various factors, including neurological, hormonal, environmental, and genetic elements. Here, we explore some of the most common…
The Science Behind Cough: Understanding Its Causes and Mechanisms
Coughing is more than just a pesky annoyance; it’s a crucial defense mechanism that protects your respiratory system. Imagine it as your body's built-in cleaning service, working tirelessly to clear out any unwanted invaders and keep your airways pristine and functional.
Understanding Oral Ulcers: Pathophysiology, Causes, and Treatment Strategies
Oral ulcers, commonly known as canker sores, are open lesions that occur inside the mouth. They can develop on the inner lining of the cheeks, lips, tongue, floor of the mouth, and even the gums. While they can be a source of considerable discomfort, it's important to understand that oral ulcers…
Understanding the Pathophysiology of Mucositis: Causes, Symptoms, and Treatments
Mucositis is a condition that manifests as painful inflammation and ulceration of the mucous membranes lining the gastrointestinal tract. This debilitating condition is commonly observed in patients undergoing cancer treatments such as chemotherapy and radiotherapy. The symptoms can range from mild…
Understanding the Pathophysiology of Herpes: Causes, Symptoms, and Treatment Options
Herpes is a common viral infection caused by the herpes simplex virus (HSV). There are two primary types: HSV-1, which typically causes oral herpes, and HSV-2, which is more often associated with genital herpes. Despite their differences, both types share similarities in their pathophysiology and…
Understanding Pharyngitis: Causes, Symptoms, and Pathophysiology Explained
Pharyngitis, commonly known as a sore throat, is characterized by the inflammation of the mucous membranes of the oropharynx. This condition can make swallowing difficult and painful, often accompanied by other symptoms such as fever, headache, and swollen lymph nodes. Understanding pharyngitis…
Biopharma Innovations by Vitrobio: Leading Healthcare Solutions
Founded in 1994, Vitrobio is a French biopharmaceutical company based in Issoire, specializing in the research and development of innovative medical devices. Since its inception, the company has focused on using advanced technologies to create effective and safe healthcare solutions.
All You Need to Know About Allergic Rhinitis: Symptoms, Causes and More
If you've ever been halted mid-spring by bouts of incessant sneezing, felt your eyes water up at the sight of that blossoming tree in your yard, or found yourself surrounded by tissues during those warmer months, sweet summer may not seem so sweet after all. You might be suffering from what…
Confirmation letter of certification application framework of regulation (EU) 2017/745
We understand the value of transparent and clear communication with our clients, especially when it comes to compliance with regulatory standards. For all our partners who distribute our medical devices, we want to provide assurance of our commitment to meeting the stringent quality and safety…
EC Certificate Directive 93/42/EEC
In our commitment to providing safe and efficient medical devices, we align with internationally recognized standards. One such standard is Directive 93/42/EEC (also known as MDD), a European Union directive that sets the framework for marketing medical devices.
JAN-23 : Vitrobio Certification Update
Vitrobio is already committed to the transition to MDR. An application for certification under Annex XI part A of Regulation 2017/745 has been submitted to the GMED, for the entire product portfolio. Conformity assessment services are currently underway.
JAN-24 : Vitrobio Certification Update, Management and Ressources
Dear VITROBIO Partners and Clients,
OCT-23 : Vitrobio Certification Update, UDI and Changes
Vitrobio is already committed to the transition to MDR. An application for certification under Annex XI part A of Regulation 2017/745 has been submitted to the GMED, for the entire product portfolio. Conformity assessment services are currently underway.
Understanding the Medical Device Regulation (MDR 2017/745): A Transformative Shift in the Medical Device Industry
The healthcare landscape is ever-evolving, with regulatory frameworks often adapting to ensure safety and efficacy of medical devices. One such monumental change has been the implementation of the Medical Device Regulation (MDR 2017/745), which replaces the Medical Devices Directive (MDD 93/42/EEC)…
Vitrobio ISO 13485 certificate
In our ongoing commitment to delivering safe, efficient, and reliable medical devices, we place great emphasis on adhering to globally recognized standards. A key example of this is our certification to ISO 13485 , an international standard that specifies requirements for a quality management…
Delving into the World of Medical Devices: An Overview with a Focus on Class IIa Nasal and Throat Sprays
Understanding Medical Devices, their Classes, Market Dynamics, and a Deep Dive into the Production of Class IIa Nasal and Throat Sprays
Navigating the Transition from MDD to MDR: Legacy Devices and Marketing Authorization
The evolution of the regulatory landscape in the medical devices sector has witnessed a notable transition from the Medical Devices Directive (MDD) to the Medical Device Regulation (MDR 2017/745). With the MDR becoming effective from May 26, 2021, an important consideration in this shift is the…