Your personal guidance and professional expertise to
Medical Device and Health Care Compliance

 

design
follow up

From design to market launch and follow up

Lieven Van Landuyt
Industrial Pharmacist
Qualified in biomedical engineering
20 years of experience
Practical approach
Combines broad knowledge

Medical devices

LVL Mediphar helps you through you Medical device design - from the early start until market launch.
Guidance to Medical Device CE marking and the implementation of the European MDD 92/43 EC and ISO 13485 quality management system.

Quality Management

Active guidance in the implementation of quality system ISO 9001, ISO 13485, GDP and GMP, ISO 22716 (GMP cosmetics), HACCP.

Process approached guidance and scan of your existing documentation.

We offer services for...

Start-ups in pharma & medical sector looking for coaching and assisstance.

SMEs in pharma & medical sector looking for guidance and advice

Large corporations looking for expertise

Did you know that...

  • ISO 13485

    ISO 13485 New Edition

    ISO 13485 vers. 2016 has been published and a 3-year transition period is currently ongoing.

    Even if you have a good working QMS running, some basic GAPS needs to be tackled.

  • European flag

    New MDR

    The draft MDR is already available and you can download it here (with index)

Receive your free GAP checklist for the new ISO 13485
We would like to convince you of our expertise
Get in touch!

What our clients say about our services

Mona Lisa is a worldwide manufacturer of cupper Intra Uterine Devices.

For more than 10 years, Lieven has served Mona Lisa in quality aspects, helping make the QMS more smooth and ready for NB and client audits in several aspects like validation, risk management, internal and external auditing, etc. Lieven has helped to upgrade our class III Technical STED files with the current guidelines and establish the practical link with our quality management system. Great work!

Mona Lisa- bedrijfslogo
Frank Daniels
Mona Lisa QA Manager

While most large pharmaceutical and biotechnological companies have their own in-house teams to interpret, implement and follow up on the new GDP guidelines, many smaller companies are still working towards their GDP certification. Cogezaf was one of these companies. In a three-month period, Lieven tackled the existing QM system into a workable and practical living validated and qualified system with a multidisciplinary approach. He also provided us with the necessary training, so that we at Cogezaf could easily manage the GDP system ourselves.

Marie France Dhondt
Cogezaf QA manager