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CV Alice Ravizza_ENG_short 2014 01 31

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CURRICULUM VITAE of Alice Ravizza
Via Mazzini 42, 10123 Torino
Phone +39 011 6606310
Mobile +39 349 3621829
Email [email protected]
P.Iva 10744710012
Personal data
Place and date of birth: Basel (Switzerland), December 18, 1979
Citizenship: Italian
Fellow Engineer at “Ordine degli Ingegneri della Provincia di Torino”
Married, three children born July 2006, February 2008 and December 2011
Held Courses
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26 November 2013 At Bioindustry Park Silvano Fumero: “Design control, progettazione in
ambito GMP per compliance FDA”. In Italian
11 June 2013 At Skillab Skillab S.r.l. centro valorizzazione risorse umane Presso Unione
Industriali Torino “Prodotti delle start-up e Marcatura CE”. In Italian.
12 April 12th and May 10th, 2013 At Politecnico di Milano, esercitazioni del corso
Progettazione di Sistemi di Supporto alla Vita course “Medical devices design: from the
laboratory to the production department”. In English and Italian.
April 22nd and April 29th, 2013 At Dottorato in Tecnologie applicate alle scienze
chirurgiche, , Università di Medicina e Chirurgia, Torino, course “I dispositivi medici nella
pratica clinica e sperimentale”. In Italian.
January 2013 At Dottorato in Scienze della Vita e della Salute, Politecnico di Torino,
course: “Fabbricazione e certificazione dei dispositivi biomedici: dalla ricerca all’industria”.
In Italian.
September 2012 – October 2012 At Bioindustry Park Silvano Fumero: “Good Practices:
quattro appuntamenti per le PMI sulle tecniche di Good Documentation e di Lean
Documentation allo scopo di raggiungere i requisiti di conformità senza gravare
eccessivamente sul sistema aziendale.” In Italian.
Current projects as Free Lance Consultant- PGG Scientific CEO
Training at DNV Italy as a Medical Device Directive Technical Expert and ISO 9001 and 134985
Lead Auditor. Status: expected completion first quarter 2014
Training at Eurofins TECH as a Medical Device Directive Technical Expert and ISO 9001 and
134985 Lead Auditor. Status: expected completion first quarter 2014
Implementation of a fully compliant integrated GMP and ISO 13485 QMS for VitalMed Inc. The
company is a provider of OEM components for blood and IV sets. Located in Boston, MA (USA)
and Reynosa, Tamps (Mexico). Certification of such system according to ISO 13485 standard.
Reference NB: TUV and DNV. Establishment registration at FDA as Contract Manufacturer.
Clinical Post Market follow up for a class IIa medical device, patented extracorporeal blood circuit,
for Haemotronic spa. The company is a manufacturer of medical devices for haemodialysis,
peritoneal dialysis, infusion and transfusion and a manufacturer of OEM components.
For the same device, 510(K) submission foreseen within December, 2014.
CURRICULUM VITAE of Alice Ravizza
External reviewer for the development of the next generation of a class IIa medical device, patented
extracorporeal blood circuit, for Haemotronic spa.
CE marking of a second generation class III medical device: bone graft with animal origin
substance for dental applications for Nobil Bio Ricerche s.r.l. The company is a provider of surface
treatments for dental implants, a supplier of laboratory analysis for surface characterization and the
manufacturer of this innovative implantable medical device. Full responsibility of Product and
Process Validation planning, Risk management, Clinical evaluation, auditing management.
Reference NB: DNV. Status: Design in progress
Main projects developed as Free Lance Consultant- PGG Scientific CEO
CE marking of a class I stand alone SW for Brainer s.r.l. Full responsibility of SW Validation
planning, Risk management, Clinical evaluation and publication policy. Status: device registered at
Ministero della Sanità
CE marking of a class III medical device: bone graft with animal origin substance for dental
applications for Nobil Bio Ricerche s.r.l. Full responsibility of Product and Process Validation
planning, Risk management, Clinical evaluation, auditing management. Reference NB: DNV.
Status: Certification pending approval
Implementation and maintenance of a fully compliant integrated GMP and ISO 13485 QMS for
Nobil Bio Ricerche s.r.l. Certification of such system according to ISO 13485 standard. Reference
NB: Certiquality
Clinical investigation (literature based) of a Automated External Defibrillator for CE Technical File
and SFDA (China Food and Drug Administration) compliance for Progetti s.r.l. The company
designs, develops and manufactures multiple Electro-Medical devices in class IIa and IIb.
Reference NB: Istituto Masini
Implementation and maintenance of a fully compliant integrated GMP and ISO 13485 QMS for
Biotechware s.r.l. The company is a start-up at I3P Politecnico di Torino and a manufacturer of an
innovative ECG monitor. Certification of such system according to ISO 13485 standard completed.
Reference NB: Italcert
CE marking of a custom made, wearable orthopedic device (orthesis) for hand function replacement
for Functionable srl a start-up company at I3P Politecnico di Torino. Full responsibility of Product
and Process Validation planning, Risk management. Status: device registered at Ministero della
Salute
Course “La progettazione dei dispositivi medici” for QualitySystems at a customer site. 16 July
2013
Main Projects developed at Haemotronic S.p.A: Engineering
Patents- Patents pending
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“KIT FOR THE EXTRACORPOREAL TREATMENT OF A BIOLOGICAL FLUID OF A
PATIENT, AND UNIT PROVIDED WITH SAID KIT” EP2160213 (A2) marketed as
device Chiaraset
CURRICULUM VITAE of Alice Ravizza
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“CHECK VALVE FOR A MEDICAL DEVICE “WO2009031018 (A2)
” CATHETER FLUSH AND FILL UNIT” WO2009147510 (A1) marketed as device
Haemocatch
“SACCA A PIU' COMPARTIMENTI PER SOSTANZE MEDICALI IN MATERIALE
MULTISTRATO”, ITTO20050083 (A1)
Validations and Design Transfers
IQ-OQ-PQ and statistical analysis for process capability on manufacturing equipment for injection
molding, extrusion, thermal welding, ultra-sound welding, radio-frequency welding, automatic
assembly and manual assembly.
Design, validation and certification according to Machine Directive of automatic assembly
machines.
Design and installation of manufacturing equipment in new sites, process validation and personnel
training. Sites in Medolla (Italy) and Reynosa (Mexico) and for a customer in Wuxi (China).
Design, validation and classification of ISO class 8 clean-rooms. Sites in Medolla (Italy) and
Reynosa (Mexico).
Main customers: Nutricia - Wuxi, ACS, Mergon, Baxter, Fresenius Medical Care – North America
Main Projects developed at Haemotronic S.p.A: Quality Assurance and Regulatory
CE Marking according to Annex II MDD for medical devices in classes III and IIa (extracorporeal
blood circuits with and without heparin coating for dialysis applications, including patented devices
see above; enteral and parenteral nutrition sets; IV sets)
Quality System compliance to applicable European and International norms and laws, i.e. GMP,
ISO 13485, Directive 93/42/CEE and following modifications and revisions, ISO 14971, series ISO
10993, series ISO 14644, series ISO 14155 and Meddev, process and product technical norms.
Implementation of a fully compliant integrated GMP and ISO 13485 QMS in the manufacturing site
of Reynosa, Mexico. (subcontractor of OEM components and subassemblies). Certification of such
system according to ISO 13485 standard.
Main customers: Baxter, Edwards, Teva, Baxa, Fresenius Medical Care – North America
Education and Languages
Biomedical Engineering Degree at Politecnico di Milano.
Mother tongue: Italian
English: bilingual proficiency. CPE certificate.
Spanish: conversational proficiency.
German and Chinese: elementary – beginner proficiency
Autorizzo il trattamento dei dati personali ai sensi del D. lgs. 196/03
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