Services

Regulatory Affairs

Regulatory strategy

Is my software a medical device ?

Identify which standards and regulations apply to your device.
Definition of the device class.

CE MARKING

Preparation & Update of the Technical File in accordance with the MDR 2017/745 Regulation

INTERNATIONAL SUBMISSION

Regulatory Registration and Submission Internationally (USA, Canada, …)

Quality Assurance

QMS IMPLEMENTATION

Implementation and improvement of the quality management system
ISO 13485

QMS COMPLIANCE

Compliance of the QMS with regulatory requirementsMDR 2017/745 – MDSAP

MONITORING

Regulatory and standardization monitoring

INTERNAL AUDIT

Ready to move your project forward ?

Questions about regulations, CE mark, QMS ?