GIANLUCA TORDI
TSQ GLOBAL

I’m a Biomedical Engineer with long experience in the consulting fields. I worked in several project for Osteosynthesis, Endoscopic, Combination Device, Bone Substitutes, Software as Medical Device with different roles and responsibilities from R&D to Regulatory, Quality and Process Validation.
I’ve supported companies ranging from innovative start-up (so developing at the same time the product and the process to realize and control it) to mid-size companies and bluechips (so focusing on details and worldwide regulatory compliance challenges) in the field of medical device and pharma. TS Q&E is a ISO 13485:2016 certified consulting service provider, that can support as external partner, take ownership of some part of the project or deliver full projects.
Design and Development Medical Device: Orthopaedics, Traumatology, Neuro, Cardio, Surgical instruments Class I, Class II, Class III.
Regulatory Support: New MDR 2017/745 support, DHF, Tech File, Clinical Evaluation, Design Dossier, 510k, Risk file, Remediation project.
Quality Support: ISO 13485 Certification Support, Internal and External Auditing, SOP and Process Gap Analysis.
Process Validation: URS, VMP, DQ/IQ/OQ/PQ, GAMP5, FAT, SAT, FS, HDS, SDS.
Training on Regulatory and Quality Topics: NEW MDR 2017/745, CAPA, PMS, Tech File, ISO 13485 Internal Auditor