Principal Consultant, MDR Lead
The key expertise areas of Giovanni
- Expert advice on CE certification and CE strategy for medical devices, including high risk, combination devices and devices containing animal tissue Regulatory advice, set up, preparation or review of technical documentation in support of compliance with the Medical Device Directive 93/42/EEC or the Medical Device Regulations 2017/745
- Assessment, gap analysis and remediation strategy for Clinical Evaluation Reports and PMCF against the requirements of MEDDEV 2.7/1 rev. 4, MEDDEV 2.12/2 rev. 2 or Medical Device Regulations 2017/745
- Strategic advice on PMS, PMCF (including PSUR) and clinical evaluations consultations (per art. 54 MDR)
- Regulatory advice or review of labeling, instructions for use, marketing material and Summary of Safety and Clinical Performance (SSCP)
- Detailed knowledge of the Medical Device Regulations 2017/745
- Expert advice on Notified Body selection and interaction
- Technological/Product expertise in the following areas: vascular and neurovascular stents, surgical and transcatheter heart valves, surgical and transcatheter valve repair devices, cardiac occludes, vascular and cardiovascular catheters (including angioplasty, electrophysiology, CVC's, etc.) emboli protection devices, implantable ports, embolization devices (including embolization beads)
Giovanni has 20 years of experience in the medical devices field, ten of which have been spent at two major Notified Bodies, TÜV SÜD and BSI.
Throughout this period Giovanni assessed over 400 design dossiers or technical files of high-risk devices in the cardiovascular, endovascular and neurovascular field, including drug-device combinations, absorbable devices and devices containing animal tissue and has overseen the assessment of many more.
He conducted several unannounced audits and QMS audits, in the role of technical assessor. He was heavily involved in the MDR project and was a qualified internal and external MDR trainer for TÜV SÜD.
Giovanni has a degree in mechanical engineering from the Polytechnic University of Turin
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