Case Study 5 : Regulatory, Clinical and Commercial Partners For CE-IVD Device in Japan for IVD
Company Situation Client’s IVD product was classified as Class III in Japan and required a clinical trial to be done locally. There was no similar
Case Study 51: Registration of DMF Type II with FDA
Client was looking for a local agent to support the registration of a type II DMF with the FDA for the serum CellCor.
Registration of Glucometer (Class III In-Vitro Diagnostic) in Japan
The Client is a South Korea based medical devices manufacturer who has developed a glucometer that it wanted to launch in Japanese market.
Investigational Device Exemption (IDE) Preparation and Submission to FDA
The Client is a China based invitro diagnostic kits manufacturer planning to launch its IVD kits for Human Papilomavirus (HPV) detection kits in USA and was seeking a partner to provide a clinical investigation strategy for the kit and support with preparation and submission of investigational device exemption (IDE) application to FDA.
GCTP Quality Audits of Blood Products Collection and Processing Centers
American based company specialized in the collection, processing, and donor-recipient matching of blood products in USA asks GRP’s GCTP auditors to cover 35 audits in the USA.
Case Study 52: 510(k) Application for Artificial Intelligence based Software as Medical Device
AI- software company with products already registered in EU, USA, and Japan seek GRP to register a new AI based software in USA via 510(K) application process.