We offer a comprehensive range of testing solutions for the development and validation of IVD products as part of medical device authorization. Our holistic approach covers method transfer and validation according to European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines ensuring conformance to each market’s requirement for quality and performance. For devices and assays we ensure regulatory compliance. Beside the organization of appropriate patient samples or relevant reference materials all solutions are delivered on time with years of experience and ready-to-use reports for your approval process.
Why choose IVD medical device qualification services from SGS?
With more than 30 years of experience we can meet your needs according to the highest quality standards 24/7, 365 days a year. We rely on our global network to offer you a holistic service from a single point of contact.
We are recognized as the benchmark for quality and integrity in IVD qualification services for the pharmaceutical and biotechnology industry. With more than 3,000 completed studies and projects, we are your perfect partner for all aspects of your project.
The Garden Centre 2nd floor,
Cilandak Commercial Estate, 12560,
South Jakarta, Special Capital Region of Jakarta, Indonesia