Michael Maier Email & Phone Number

Veranex Solutions provides expertise from concept to commercialization in Regulatory Affairs, Clinical Affairs and Quality Management System compliance for Medical Device and IVD projects - whether you are working on product innovation or strive to maintain compliance for legacy products. Our experts assist you during all steps of a medical device development, from the initial project idea over the design & development to certification, regulatory clearance and beyond. As a global organization, we are close to you anywhere.Specialties: Regulatory Affairs for Medical Devices, Regulatory pathways, Clinical pathways, Compliance Programs, Auditing of Quality Systems (Internal / Supplier / Certification / Notified Body Audits) in an ISO 13485 environment, MDSAP and FDA mock inspections. Support for V&V, Assessment of technical documentation, liaison with Competent Authorities and regulatory bodies. Full service CRO for medical device clinical investigations.

Listed skills include Iso 13485, Medical Devices, Quality System, Fda, and 46 others.