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Formulated Medical device or combination product- can be a cream!
There are many formulated products that are medical devices such as creams for eczema, wound healing gels or sprayable band aids. There are also medical device combination products, such as patches with gel or different injections. With extensive experience in the field, RISE can help you bring your medical device idea to the market!
When thinking of a medical device, one might think of a thermometer, an advanced instrument in a hospital, or possibly a band aid. That’s entirely correct, but there are also many formulated products that are medical devices, such as:
• Skin cream/skin lotion for eczema or psoriasis
• Wound healing products
• Gel used to prevent scarring after surgery or burns
• Lubricants
• Contact lens solutions
• Chemical plasters such as sprayable band aid
• Diagnostic solutions containing for example nano-particles
But also combination products such as:
• Patches containing wound healing formulations
• Fillers for wrinkle treatment (where both the syringe and the formulation can be medical devices)
A medical device should diagnose, prevent, treat or alleviate diseases but without containing immunological, pharmacological or metabolic active substances. This means that the medical device formulation should instead contain substances that work with physical impact such as protective, volumizing or strengthening in various ways.
How can RISE be of help?
With extensive experience and expertise in the field, RISE can help you bring your formulated medical device product to the market by:
• Formulating and characterizing initial prototypes
• Consulting on both technical and quality issues as well as planning your product development
• Toxicological evaluation and studies
• Proposing and/or developing and validating test methods
• Initial and formal stability studies
• Scaling up and process development
• Production of prototype for clinical studies (according to GLS or GMP)
• Analysis package