I have extensive experience, insight and knowledge in Quality Systems especially regarding medical devices. I have hands on experience over many years and can contribute with training, coaching and auditing regarding quality systems, especially related to medical devices. I have prepared for and participated in 20+ FDA inspections. I have audited numerous sites for compliance to FDA regulations, requirements in MDD, ISO 13485, ISO 14971 and ISO 9001.
I can adapt and hold training on various related topics.
If you need my experience and knowledge, contact me!
Experience and insight in clinical settings
To design and maintain efficient Quality Systems requires experience, insight and knowledge.
To comply with requirements in standards and regulations requires experience, insight and knowledge.
To pass Notified Body audits requires experience, insight and knowledge.
To prepare for, and execute efficiently during FDA inspections requires experience, insight and knowledge.
To achieve detailed and complete audits you need experience, insight and knowledge.
Knowledgeable and experienced trainer.
Experienced auditor in various settings
Excellent communication skills
Tel: +47 93215620