EU, US, China, Japan, Arabian Countries.
Decomplix simplifies market access for medical devices by offering certification for mobile medical apps and wearables in significantly less time. Developers get to concentrate on their core business of innovation, design, marketing and development as Decomplix takes over responsibility for obtaining and maintaining the CE marking for the product. Decomplix is a joint venture between established companies and professionals with a mission to accelerate innovation and encourage the increased breakthrough of great ideas.
Areas of regulatory/reimbursement support:
Decomplix takes over responsibility by acting as a legal manufacturer, with medical devices being certified under Decomplix’ name. Decomplix reviews development, guides and supports in diverse fields like risk management, compiling and overseeing completion of the technical documentation to standards. It handles the certification procedure with its Notified Body. After product launch, Decomplix is the official point of contact for authorities and complaints of end-users as well as ensuring hassle-free certification maintenance. Competencies include post-market surveillance, complaint handling, incidents and periodic reportings and management reviews.