Sander Consult is a consultancy specializing in Regulatory Affairs Services, with a focus on Medical Devices and Combination Products.
Sander Consult provides services to Medical Device Manufacturers, as well as other EU Economic Operators and Stakeholders. As a trusted partner, our primary goal is to guide our clients through the intricate regulatory landscape, verifying that the safety and performance of the medical devices are documented in accordance with applicable regulations and standards.
Sander Consult provides services within Regulatory Affairs such as:
MDR Compliance
Technical Documentation
High Risk products
Regulatory Intelligence
Courses
MDR Compliance
Technical Documentation
High Risk products
Regulatory Intelligence
Courses
Product Classifications
Presubmissions
Product Approval Submissions
Competent Authority Dialog
Product Classifications
Presubmissions
Product Approval Submissions
Competent Authority Dialog
Regulatory Affairs Support
Day-to-Day on site/off site support
Notified Body Dialog pre/post Certification
Lifecycle Mangement
Regulatory Affairs Support
Day-to-Day on site/off site support
Notified Body Dialog pre/post Certification
Life-cycle Mangement
Liselotte Sander
Sander Consult was founded in 2018 by Liselotte Sander, who holds a master’s degree in pharmacy and possesses over 25 years of experience in the complexities of Medical Device Regulations. Her expertise has been honed through her previous roles at companies such as Novo Nordisk, Agilent, Presafe Denmark, Ferrosan, and Medtronic.
Liselotte Sander
CVR no: 39666898
