HARBIOS is a CRO company specializing in providing product lifecycle services to medical device research institutes, R&D and manufacturing companies, as well as relevant regulatory agencies, and has a expertise team from different academic background with extensive experience. Mid-Link's business covers device's whole lifecycle, including consulting service, QMS establishment and audit, performance testing, biocompatility evaluation, pre-clinical testing, clinical evaluation, CMO/CDMO, in-country representative..

When your product isin conceptual "seeding" phase, Mid-Link can provide services such as Regulatory survey, strategic planning for global market access, predicatedEquivelent / Predicated device survey, Contract service of scientific research, and commercialization of scientific and research findings, to advance the concept to the design and development stage.

When your product is in the "growth" phase as design and, Mid-Link can provide design, development and production, testing, clinical evaluation and regulatory consultation services.

When the product is in the realized "maturity" phase, Mid-Link can help you complete the registration, certification or listing of the product in more than 100 global markets, including 510(k) and PMA application in the United States, NMPA registration and listing in China, CE certification in EU, ANVISA registration in Brazil and HC registration in Canada.

When a product is in the launched "harvest" phase, Mid-Link can provide the services of representatives in various countries, post-market clinical followup, adverse event management, product recalls, regulatory survey and planning for product changes/iterations, registration/certification changes, and product withdraw.

HARBIOS GROUP