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
Qualification in biomedical engineering
20 years of experience
Practical approach
Combining broad knowledge

Medical devices

LVL Mediphar helps you trough 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.

SME's 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 years transition period is running.

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

  • New MDR

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

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

What our clients say about our services

MonaLisa is worldwide manufacturer of cupper Intra Uterine Devices.

For more than 10 years, Lieven has served Monalisa in quality aspects helping the QMS system 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 practical link with our quality management system.

Great work !

 

Frank Daniels

QA manager Monalisa 

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 3 months period Lieven has tackled the existing QM system into a workable and practical living validated and qualified system, with a multidisciplinary approach. By giving the necessary training, Cogezaf could easily manage the GDP system their selves.

Marie France Dhondt

QA manager Cogezaf