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