Medical Device Clinical Trial

In China, clinical trials of medical devices and diagnostic reagents have certain specificities under its domestic regulatory environment. In order to achieve better delivery, CR Medicon established a dedicated medical device team and set up a quality assurance system that meets China's domestic regulatory requirements.

Services

  • PMA (premarket approval) and PMS (post-market surveillance) phases
  • High-risk medical device
  • Class II medical device
  • IVD
  • Support investigator initiated trials (IITs).

Advantages

  • Rich experience in cardiovascular stents (drug-eluting stents, drug-eluting balloons, bio-degradable stents, cardiac occlusion devices, percutaneous transluminal atherectomy, aortic stents, etc.) as well as in ophthalmology and reproduction specialties
  • An independently established clinical operations SOP that fully satisfies regulatory requirement for medical devices and IVDs
  • A number of senior clinical trial project managers for medical devices and IVDs
  • In-depth collaboration with medical device KOLs in various specialities, both in China and around the world.
  • Familiar with medical device related regulatory requirements and can provide constructive opinions in regulatory registration.
微信公众号