It can be challenging for small companies to navigate the medical device regulatory pathways, especially when the team lacks the industry experience. This was the case for SOLIUS. After realizing the limitations this posed on their companies goals, they were able to achieve great results from quickly implementing Greenlight Guru, like receiving their ISO 13458:2016 certification. SOLIUS was founded by a duo seven years ago, but their product development eorts have ramped up in the past several years. Their device is a Class II phototherapy device that bridges a medical device and a wellness device that stimulates the body to produce Vitamin D–something the body is already meant to do. SOLIUS’ device is the first of its kind in terms of its labelling and conditions for use. This m

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