CV Alice Ravizza_ENG_short 2014 06 08

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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9 May 2014 and 16 May 2014 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.
13 March 2014 “MEDICAL DEVICE: come soddisfare ISO13485 e 21CFR820” for Quality
Systems Srl- Training & Consulting
10 January 2014 at Politecnico di Torino, esercitazioni del corso Progettazione di Sistemi di
Supporto alla Vita course “Introduzione ai dispositivi medici: le norme relative alla
validazione dei dispositive biomimetici. Case report: riempitivo d’ osso biomimetico”
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
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MDD technical Expert for DNV GL
Training at DNV GL Italy and at Eurofins TECH as ISO 9001 and 134985 Lead Auditor.
Status: expected completion third quarter 2014
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
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External reviewer for the development of the next generation of a class IIa medical device,
patented extracorporeal blood circuit, for Haemotronic spa.
Regulatory consultant for Haemotronic s.p.a as part of the PVC Free Blood Bag programme
http://www.pvcfreebloodbag.eu
Post market Clinical Follow Up management for a class III medical device: bone graft with
animal origin substance for dental applications for Nobil Bio Ricerche s.r.l.
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 GL. Status: Design in progress
Main projects developed as Free Lance Consultant- PGG Scientific CEO
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2013 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).
2013 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
2014 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: Certificate issued
2013 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
2013 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
2013 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
2013 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
Main Projects developed at Haemotronic S.p.A: Engineering
Patents- Patents pending
• 2010 “KIT FOR THE EXTRACORPOREAL TREATMENT OF A BIOLOGICAL FLUID
OF A PATIENT, AND UNIT PROVIDED WITH SAID KIT” EP2160213 (A2) marketed
as device Chiaraset
• 2008 ” CATHETER FLUSH AND FILL UNIT” WO2009147510 (A1) marketed as device
Haemocatch
• 2007 “CHECK VALVE FOR A MEDICAL DEVICE “WO2009031018 (A2)
CURRICULUM VITAE of Alice Ravizza
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2005 “SACCA A PIU' COMPARTIMENTI PER SOSTANZE MEDICALI IN
MATERIALE MULTISTRATO”, ITTO20050083 (A1)
Validations and Design Transfers
• 2003 – 2013 IQ-OQ-PQ and statistical analysis for process capability on manufacturing
equipment for injection molding, extrusion, thermal welding, ultra-sound welding, radiofrequency welding, automatic assembly and manual assembly.
• 2011 Design, validation and certification according to Machine Directive of automatic
assembly machines.
• 2008- 2012 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).
• 2008-2012 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
2002- 2013 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)
• 2004- 2013 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.
• 2008-2009 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
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Education and Languages
2003 Biomedical Engineering Degree at Politecnico di Milano.
Mother tongue: Italian
English: bilingual proficiency. CPE certificate.
Spanish: conversational proficiency.
German and Chinese: elementary – beginner proficiency
Other
Secretary at A.Tom.I. ONLUS
Autorizzo il trattamento dei dati personali ai sensi del D. lgs. 196/03
Per la veridicità dei dati sopra riportati si richiama il D.P.R. 445/2000 in caso di dichiarazioni non veritiere “Testo Unico
delle disposizioni legislative e regolamentari in materia di documentazione amministrativa”

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