Medical Devices – In-vitro Diagnostics – Pharma
Explore our services for your R&D, Quality and Regulatory Affairs departments
Product performance as well as patient safety and efficacy are the overarching key characteristics for products in life science and need to be assured during the whole product life cycle.
We support our customers by providing expertise and skills to take the smartest route to registration for all kind of devices from single-use plastics, to electrics, electronics with integrated software or AI respectively stand-alone software or AI.
Regulatory
It is essential, to determine the Regulatory Strategy as early as possible so you are able to follow the straightest route from development to product registration and marketing.
This starts with correct product classification, followed by identifiying region/country specific regulatory requirements and product specific norms and standards.
We are familiar with international requirements coming from Authorities, Notified Bodies and Competent Bodies and will accompany your journey in the EU, US and markets in the rest of the world.
General Safety and Performance Requirements
For registration in Europe the technical files of medical devices or IVDs must show evidence, that applicable GSPRS in MDR/IVDR Annex I are fulfilled.
