Expert guidance
for medical devices, compliance & CE marking
From design to market launch and follow up
Guiding the creation of safe and compliant medical devices from the very first concept.
Design & development
CE certifciation
Post-market follow-up
Preparing documentation, ensuring regulatory compliance, and supporting a successfulCE-marked market launch.
Monitoring performance, managing post-market obligations, and supporting ongoing quality and safety.
About us
Lieven
Van Landuyt
Provides consultancy in Medical Device Regulatory affairs and Quality Systems. With more than 2 decades of experience in pharmaceutical GMP/GDP compliance and Medical device design, production and approval, we are your preferred partner for your project.
Qualified auditor in the following domains:
20+ years
Of experience in pharmaceutical GMP/GDP compliance and medical device design, production and approval.
Industrial pharmacist
An experienced industrial pharmacist with deep insight into regulated healthcare environments.
Services
Medical devices
LVL Mediphar helps you through you medical device design – from the early start until market launch.
Expert guidance to Medical device CE marking and the implementation of the European Medical Device regulation (MDR) EU 2017/745.
Quality management
Active guidance in the implementation of quality system, ISO 13485, GDP and GMP.
Process approached guidance and scan of your existing documentation.
Clients
Start-ups
Start-ups in pharma & medical sector looking for coaching and assisstance.
SME’s
SMEs in pharma & medical sector looking for guidance and advice.
Large corporations
Large corporations looking for expertise.
Contact
LVL Mediphar bvba
Scheurestraat 7
9850 Landegem, Belgium
BE 0862 946 642
+32 475 37 78 43
lieven.vanlanduyt@icloud.com