Building and maintaining good quality systems requires experience, insight and knowledge.

Meeting requirements set in quality standards requires experience, insight and knowledge.

Completing audits with Notified Body requires experience, insight and knowledge.

Preparing and conducting inspections with the Food and Drug Administration (FDA) requires experience, insight and knowledge.

Getting detailed and good quality audits requires experience, insight and knowledge.

Why your company should engage me.

I have extensive experience, insight and knowledge in quality systems in general and for medical products in particular. I have worked with this for many years and can contribute with training, guidance and revision related to quality systems, especially in the field of medical products. I have prepared and participated in over 20 FDA inspections and have audited many companies against the FDA regulations, the requirements of MDD and ISO 13485, ISO 14971, as well as ISO 9001.

Training and courses: I hold customized courses

I have experience and insight from different clinical environments.

I have extensive experience in audits of quality systems.