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 medical device documentation is in accordance with applicable regulations and standards.


Regulatory Affairs

Sander Consult provides services within Regulatory Affairs such as:

Regulatory Compliance


MDR Compliance

Technical Documentation

High Risk products

Regulatory Intelligence

Courses


Regulatory Compliance


MDR Compliance

Technical Documentation

High Risk products

Regulatory Intelligence

Courses

Drug-Device Combinations 


Product Classification

Borderline products 

Presubmissions

Product Approval Submissions

Competent Authority Dialog



Drug-Device Combinations


Product Classification

Borderline products

Presubmissions

Product Approval Submissions

Competent Authority Dialog


Regulatory Affairs Support


Day-to-Day on site/off site support

Notified Body dialog pre/post Certification

Life cycle Management


Regulatory Affairs Support


Day-to-Day on site/off site support

Notified Body dialog pre/post Certification

Life cycle Management


Liselotte Sander

RA Consultant

MSc. Pharm

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.

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