Regulatory Compliance
To address technical and clinical requirements without regulatory uncertainty.
MDR Compliance - Medical Devices
We support medical device business operators in complying with Regulation (EU) 2017/745, from design, preparation of technical documentation, to clinical and/or performance data collection.
We support the client in the management of:
- interaction with the Notified Body
- regulatory strategy definition and classification
- GSPR and risk management
- Clinical Evaluation (CEP & CER)
- PMS and PMCF
- audit preparation
IVDR Compliance - In Vitro Diagonal Medical Devices.
We support IVD business operators in the implementation of Regulation (EU) 2017/746, from design, preparation of technical documentation, to clinical and/or performance data collection.
We support the client in the management of:
- interaction with the Notified Body
- IVDR strategy definition
- Performance Evaluation (PEP, PER)
- PMS and PMPF
- requirements for performance studies
- audit preparation
Check out the collection of frequently asked questions we receive:
FAQ - In Vitro Diagnostic-Diagnostic Devices (IVD) | IVDR
Are you looking for an experienced and reliable CRO for medical device consulting?
We design and manage all phases of the clinical investigation through our team of highly qualified professionals.