Maical is a medical device specialist with more than 6 years’ experience in global and mid-size medical device organizations in the fields development, quality and regulatory affairs.
In his previous role as manager R&D (medical device product class IIb), he had the responsibility for the department R&D, development activities, budget, project planning and communication with suppliers.
Maical is an expert in the field of IQ/OQ/PQ, onbody injectors and technical file documentation according to ISO 13485. In addition, he is experienced in supplier selections, manufacturing processes, process and product development, establish/rework/update/life QM-Systems as well as conduct risk assessments according to ISO 14971.
- Anticonvulsant (epilepsy)
- Agonists (migraine)
- Angiographie (X-Ray Tables)
- digital signal and image processing
- Advanced Therapy Medicinal Product (ATMP)