Experience

B. & B. DENTAL S.R.L.
• Italy
• Medical Equipment Manufacturing
• 1 - 100 Employee
• Specialista aziendale

  • Sep 2022 - Present


KiwaCermet

• Auditor

  • Mar 2021 - Aug 2022

  Dal 15 marzo 2021 auditor, final reviewer e decision maker per il settore medicale (ISO 13485, ISO 9001, Direttiva 93/42 CEE e Regolamento 2017/754) Dal 15 marzo 2021 auditor, final reviewer e decision maker per il settore medicale (ISO 13485, ISO 9001, Direttiva 93/42 CEE e Regolamento 2017/754)


Kiwa Italia
• Italy
• Professional Services
• 100 - 200 Employee
• Auditor

  • Mar 2021 - Aug 2022


Studio Ing. Panciroli di Fulvia Panciroli

• Free lance

  • May 2018 - Mar 2021

  Free lance – consultant quality system, European medical device directive, MDSAP regulation, Taiwan regulation and environmental system In parallel: Agreement with TUV Italia -TUV SUD Product Service (Munich) as lead auditor and technical expert in medical devices field ISO 9001, ISO 13485 and EU Directive 93/42EECm MDSAP Regulation Free lance – consultant quality system, European medical device directive, MDSAP regulation, Taiwan regulation and environmental system In parallel: Agreement with TUV Italia -TUV SUD Product Service (Munich) as lead auditor and technical expert in medical devices field ISO 9001, ISO 13485 and EU Directive 93/42EECm MDSAP Regulation



Officine Ortopediche Rizzoli

• Italy
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Operations manager

  • 2017 - May 2018

  The company is specialised in manufacturing of artificial lower limbs, coupled with lines for the production of pediatric aids, body and limb braces and stabilizers. Distribution of equipments for orthopedics and rehabilitation field. I'm operation manager of: production purchasing warehouse andmistration Human resources R&D management control The company is specialised in manufacturing of artificial lower limbs, coupled with lines for the production of pediatric aids, body and limb braces and stabilizers. Distribution of equipments for orthopedics and rehabilitation field. I'm operation manager of: production purchasing warehouse andmistration Human resources R&D management control



TÜV Italia

• Italy
• Business Skills Training

• Lead auditor for TUV Italia and TUV SUD Product Service

  • 2000 - 2016

  Free lance – consultant quality system, European medical device directive, Canadian medical devices regulation, Taiwan regulation and environmental system In parallel: Agreement with TUV Italia -TUV SUD Product Service (Munich) as lead auditor and technical expert in medical devices field ISO 9001, ISO 13485 and EU Directive 93/42EEC Free lance – consultant quality system, European medical device directive, Canadian medical devices regulation, Taiwan regulation and environmental system In parallel: Agreement with TUV Italia -TUV SUD Product Service (Munich) as lead auditor and technical expert in medical devices field ISO 9001, ISO 13485 and EU Directive 93/42EEC



S.A.M.O. S.p.A.

• Italy
• Machinery Manufacturing

• Quality manager and Regulatory Affairs

  • 1997 - 2005

  Company specialized in the design and manufacture of implantable prostheses for hip, knee, hand, devices for dental implants, fixation devices, surgical instruments, sterile containers and related accessories, selling equipment and other biomedical products. Quality manager and Regulatory Affairs Coordinator for activities related to the quality / environment / safety for the SAMO and two companies of the same Group: Biomimetic Technologies and NanoSurfaces, specializing in surface treatments on metals such as tumbling, sandblasting, passivation, electropolishing, special coating on titanium. Preparation of the technical files required for EC certification for medical devices. Show less



Comef s.r.l.

• Italy
• Medical Equipment Manufacturing
• 1 - 100 Employee

• QA manager, Responsible for processes reengineering

  • 1994 - 1997

  Company specialized in injection molding of plastic components for lines dialysis, infusion, transfusion and in the design and construction of molds for the production with CNC machines. QA manager, Responsible for process reengineering • Quality Assurance Manager Company Comef • Quality Assurance Manager Company Emo (S. Prospero-MO – Same property of Comef), specialized manual assembly lines for dialysis, infusion, transfusion and accessories for biomedical and sale of finished products sterilized by EtO, Gamma, Beta. • Responsible for process reengineering (BPR) of the company Comef Show less