Regulatory Services and Strategies
The regulatory landscape can be difficult to navigate as it requires up-to-date knowledge and experience. Medical Device Consult can guide your company through the jungle of regulations and establish the optimal strategic path to CE-mark, device registration and/or approval outside EU.
As the industry moves from the Medical Device Directive (AIMD, MDD and IVDD) to the Medical Device Regulations (MDR/IVDR), we can identify the implications on the regulatory requirements and your QMS.
- Labelling and IDI requirements
- Classification of Medical Devices and establishment of a Regulatory Strategy dependant on the Intended Use and the markets, you wish to serve
- MDR/IVDR Gap analysis
- Risk Management
- Establishment of the Design History File, Technical File and Medical device File.
- Establishment of 510(k) submissions to US FDA
- Support in selection and handling of materials and in preparation of Biological and Clinical evaluations.
Notified Bodies, Regulatory Authorities and submissions
We take care of device approval submission, liaison with Notified Bodies and Regulatory Authorities.
Henrik Kvistgaard can act as your qualified person
Post Market Surveillance
We can assist with vigilance and MDR-reporting, post market surveillance and periodic safety update reporting