Our Team

PRESIDENT

MARIA DONAWA, M.D.

Maria E. Donawa, M.D. is a medical device regulatory expert with over thirty years of experience, with a focus on clinical evaluation, clinical data requirements, and clinical strategy for the European and US markets, particularly in complex or high-risk regulatory scenarios. A former official of the United States Food and Drug Administration Center for Devices and Radiological Health, she has worked in regulatory consulting since 1986 and founded Donawa Lifescience, based in Rome, Italy.

Dr. Donawa holds US degrees in pharmacy and medicine, with a post-doctoral specialty in clinical and anatomical pathology. She served for five years as a United Kingdom Institute of Quality Assurance registered lead auditor conducting Notified Body audits for compliance with the Medical Devices Directives. She is an active stakeholder member of the European Commission CIEPSE Working Group, contributing to the development of European clinical investigation and clinical evaluation guidance, and a longstanding member of ISO TC Working Group 4, which develops international standards for medical device clinical investigations and clinical evaluation.

Dr. Donawa assists medical device manufacturers in complying with European and US clinical data requirements and developing effective clinical data strategies, supporting successful regulatory submissions and compliance with MDR requirements. Her work includes the development of Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs), as well as support for post-market clinical follow-up (PMCF), including PMCF plans and PMCF reports.

For over 25 years, she was the regulatory affairs columnist for European Medical Device Technology and is a former member of the Board of Directors of the Regulatory Affairs Professionals Society. She publishes and presents regularly on complex regulatory and clinical data issues.

VP, QUALITY AND REGULATORY

ROGER GRAY, BSc, CEng, MIMechE

Based in the United Kingdom (UK), Roger Gray has worked for over 40 years in the medical device industry, specializing in European and United States regulatory and quality management requirements, in particular for electro-medical, minimally invasive and associated devices. In the early nineties, as Chairman of the Association of British Healthcare Industries (ABHI) Technical Committee and a member of the COCIR Technical Committee, Mr. Gray was closely involved with the development of the Medical Devices Directive during its formative stages, helping to present the views of UK industry to both the UK Competent Authority and European Commission. More recently, from 1998 to 2005, he was a member of the EUCOMED regulatory affairs focus group.

Mr. Gray holds a degree in Mechanical Engineering and worked in military research, automotive R&D, and technical consulting with Cambridge Consultants Ltd, a member of the Arthur D Little Group, before entering the medical device industry.

Mr. Gray held management positions at KeyMed Ltd, which has been part of Olympus Corporation, the global market leader for endoscopic equipment, since the early nineties. At KeyMed, he was responsible for Regulatory Affairs and Quality Assurance during his 29 years with the company, but also managed a variety of other departments, including manufacturing, repair, R&D, technical marketing, technical publications, and intellectual property.

Mr. Gray has participated in several European and international standards working groups including IEC SC 62D/MT 16, ISO TC 172/SC 5/WG 6 and CEN BT/TF 123. In addition, he was a member of the Editorial Advisory Board of the European Medical Device Technology magazine since its inception until its closure in 2015, regularly contributing to its conference program. Mr. Gray has also been a frequent speaker on device regulatory subjects at seminars and conferences in Europe and the US.

Mr. Gray has worked with Donawa Lifescience since 2009, and can assist you with:

• Compliance with European medical device regulatory and quality system requirements, while taking into consideration US requirements for companies marketing in both Europe and the US
• Development of Technical Files to help gain product entry into the European market via the MDD or MDR
• Generation of risk management files in accordance with ISO 14971
• Identification of relevant voluntary standards
• Development of  Pre-Subs, 510(k)s and De Novos for submission to FDA, to allow devices to gain entry to the US market
• Labelling reviews for European and US markets
• European and US post-market surveillance requirements compliance
• Obtaining and maintaining quality system certification to ISO 13485/MDD Annex II/MDR Annex IX, and US 21 CFR 820/803/806
• Assisting with quality system and technical documentation transition from MDD-compliance to MDR-compliance
• Complying with European requirements for non-European manufacturers, through the Donawa Lifescience Authorized Representative service

VP OPERATIONS AND CLINICAL AFFAIRS

DANIELA KARRER, MSc

Ms Karrer is responsible for Donawa Lifescience Consulting medical device and pharmaceutical clinical study services, including client liaison, regulatory authority and ethics committee communication, and local monitor management. She has more than 20 years’ experience in the health science field, working also as Director, Project Management with Covance Clinical Services Ltd, where she was responsible for delivery and financial performance of international oncology trials.

After graduating from Rome University, Italy with a degree in biological sciences, Ms Karrer worked first within the Italian health service and then for seven years with the Serono Group as a research scientist, before moving to Covance as a CRA in 1999. Gaining rapid promotion through the management structure, in what is one of the world’s largest drug development service companies, she was appointed Head of the Covance Italian Office and Contract Manager for alliance partners in Greece, Turkey and South Africa. She then became Director of Clinical Operations for Southern Europe, including Italy, Spain, Portugal, France, Switzerland and Israel. In this role, she was responsible for project resourcing and utilisation, target achievement and supervision of the local Clinical Operations Managers and over 100 staff.

Ms Karrer has considerable experience in project and people management in international settings, and has also gathered significant experience in clinical process improvement initiatives using ‘Six Sigma’ techniques.

VP, QUALITY AND REGULATORY

CARLO D’ALESSANDRO, MSc

Based in the Rome office, Carlo d’Alessandro holds a degree in pharmaceutical chemistry and has over 15 years’ experience in the IVD and medical device industries. Before joining DLC in 2011, he had 10 years experience working as Quality Assurance and Regulatory Affairs Manager in a multinational IVD company, directly managing implementation of its quality system in accordance with ISO 13485:2003. In this role Mr. d’Alessandro was also responsible for CE marking more than 200 IVD devices, including products from Annex II List A of Directive 98/79/EC (HIV, HTLV, HBsAg, HCV, HBV, HDV test kits) and also Annex II List B. His responsibilities also included the oversight of international performance evaluations in compliance with European Common Technical Specifications.

Mr. d’Alessandro has a wide experience in the development of CE Technical Files and Design Dossiers, Class II and III 510(k)s for US marketing clearance, together with the preparation of submissions for other regulatory jurisdictions, including Canada, Brazil, Mexico, Australia, Taiwan, India and China. During his experience working with IVD companies, he was also involved in the management of radioactive materials, in full compliance with European regulations for production, personnel training and protection, waste disposal, and also as official liaison with the National Competent Authorities for Radioactive Substances.

Beginning his career in a pharmaceutical company in Milan as an R&D technician with responsibility for QC analytical method validation, Mr. d’Alessandro subsequently began working in the IVD sector, managing the Raw Material Production Department in a company near Rome. In this role his main activities involved the purification and conjugation of monoclonal and polyclonal antibodies with HRPO or I125, as well as the incoming QC of biological and chemical raw materials

More recently, Mr. d’Alessandro has also assisted various medical device companies in both the IVD and general medical device field with quality system implementation and in the preparation and submission of 510(k)s for Class II spirometry and oximetry devices, and for the CE marking of other devices under the MDD/MDR.

Mr d’Alessandro has been appointed as Donawa Lifescience’s Person Responsible for Regulatory Compliance (PRRC) under the MDR and IVDR.

Mr. d’Alessandro can assist you with:

• Compliance with European medical device regulatory and quality system requirements
• Development of IVD and general medical device European Technical Files and Design Dossiers
• Compliance with CTS Annex II List A IVDs
• Obtaining and maintaining quality system certification to ISO 9001 and ISO 13485
• Preparation for Notified Body quality audits
• Process validation of manufacturing and control processes
• European and US post-market surveillance compliance
• Generation of risk management files in accordance with ISO 14971
• Identification of relevant voluntary standards for CE marking purposes
• Development of 510(k)s for US FDA
• Definition of OEM responsibilities for CE marking
• Labelling reviews for European and US markets

DIRECTOR, CLINICAL AFFAIRS

MATTEO MOSSO, MSc

Matteo Mosso holds a degree in chemistry from University of Rome ‘La Sapienza’ and has over 20 years’ experience in the conduct and management of clinical studies. Mr. Mosso began his career in the pharmaceutical industry at Merck Sharp & Dohme (MSD), first as a Clinical Research Associate and then as Project Manager, gaining wide experience in several therapeutic areas, including Cardiovascular, Endocrinology, Oncology, Neurology and Psychiatry.

Over the nine years he worked with MSD, he managed Phase I to Phase IV drug study projects, including the management and coordination of study teams from start-up to close-out, together with site pre-study inspections, on-site audits, and site follow-up activities.

Mr. Mosso subsequently worked at Covance, where he became Clinical Operations / Compliance Oversight Lead on assignment with Pfizer. In this new role he was responsible for in-country project management, oversight, and coordination of international CROs, oversight responsibilities for Phase I to III study monitoring, workload prioritization, study issue resolution, and coordination with corporate, medical, and clinical research staff and key opinion leaders.

Mr. Mosso joined Donawa Lifescience Consulting as Clinical Project Manager, based in the Rome Office, and was appointed Director, Clinical Affairs in 2020.

MANAGER, CLINICAL REGULATORY UNIT / CLINICAL PROJECT MANAGER

SILVIA PESCI, PhD

Silvia Pesci has a degree in Chemistry and a doctorate in Chemical Sciences from University of Rome ‘La Sapienza’. After obtaining her doctorate, she joined Merck Sharp & Dohme Group, working at the Istituto di Ricerche di Biologia Molecolare P. Angeletti (IRBM) for fourteen years. Her main responsibilities, as a Research Biophysicist, included the structural elucidation of lead compounds and the identification of key properties related to potency and pharmacokinetics, supporting the Drug Discovery and Preclinical Development programs of the Medicinal Chemistry and Pharmacology Departments.

Dr. Pesci joined Donawa Lifescience Consulting (DLC) in 2010, after obtaining a masters degree in ‘Sviluppo Preclinico e clinico del Farmaco’ from Università Cattolica del Sacro Cuore, Roma. Her main responsibilities at DLC include managing the departmental unit responsible for ethics committee and competent authority clinical study submissions. In addition she was appointed Clinical Project Manager in 2021, and in this role she is managing international clinical investigations with medical devices.

QUALITY ASSURANCE AND REGULATORY AFFAIRS MANAGER

ARMANDO COLELLA, MSc

Armando Colella holds a degree in Electronic Engineering from the University of Rome ‘La Sapienza’ and has been a member of the Rome Register of Professional Engineers since 2008. Mr. Colella began his career in an IVD instrument manufacturing company, first as an algorithm and software developer and then as Project Manager for all R&D activities. Before leaving the company, he was appointed Product Quality Manager, overseeing all technical and manufacturing documentation to ensure fulfillment of both customer and regulatory requirements. Mr. Colella subsequently worked as Quality Assurance Manager for a multinational manufacturer of contact lenses and lens care solutions.

During his time with these IVD and medical device companies, he was involved in the preparation for Notified Body audits and the development of Technical Files and Design Dossiers for CE marking, together with the preparation of submissions for other regulatory jurisdictions. He also managed product electrical safety and EMC testing in compliance with international standards.

Mr. Colella joined Donawa Lifescience as Quality and Regulatory Specialist, based in the Rome Office, and has since been promoted to Quality Assurance and Regulatory Affairs Manager. Mr Colella can assist you with:

• Preparation or review of Medical Device/IVD Technical Files for CE marking purposes
• Obtaining and maintaining quality system certification to ISO 9001, ISO 13485 or MDR/IVDR QMS requirements
• Preparation for Notified Body quality audits
• Preparation of EU and US Medical Device/IVD regulatory roadmaps and strategies
• Development of Pre-Subs and 510(k) submissions to the US FDA
• Registration of medical devices into the Italian database “Repertorio Dispositivi Medici”
• Assistance with drafting company procedures in accordance with ISO 9001/ISO 13485 and MDR/IVDR QMS requirements
• Generation of risk management files in accordance with ISO 14971
• Labelling reviews for European and US markets

QUALITY AND REGULATORY SPECIALIST

ANTONIO CIRIELLO, MSc

Antonio Ciriello holds a bachelor’s degree in electronic engineering and a master’s degree in biomedical engineering from the University of Rome. Mr. Ciriello began his career in a pharma manufacturing company as a Computer Systems Validation engineer, subsequently working as a Certification Engineer for a multinational manufacturer of IVD equipment, and then as a Quality and Regulatory Consultant for both IVDs and medical devices.

During his time with these companies, he was involved in the preparation for Notified Body audits and the development of Technical Files and Design Dossiers for CE marking, together with regulatory submissions for other jurisdictions. He was also responsible for product electrical safety and EMC testing in compliance with international standards.

Mr. Ciriello joined Donawa Lifescience as Quality and Regulatory Specialist, based in the Rome Office, offering clients assistance with:

• Preparation or review of Medical Device/IVD Technical Files for CE marking purposes
• Obtaining and maintaining quality system certification to ISO 9001, ISO 13485 or MDR/IVDR QMS requirements
• Preparation for Notified Body quality audits
• Preparation of EU Medical Device and IVD regulatory roadmaps and strategies
• Registration of medical devices into the Italian ‘repertorio’ database
• Generation or review of risk management files in accordance with ISO 14971
• Labelling reviews for European and US markets
• EU Authorised Representative client file management in accordance with the MDR and IVDR

CLINICAL RESEARCH ASSOCIATE (CRA)

SERENA SANETTI, MSc

Serena Sanetti graduated with a Bachelor of Science in Biological Sciences from the University of Tor Vergata, Rome, followed by a Master of Science in Biotechnology in Clinical Research from the same university.

Prior to joining Donawa Lifescience, Ms. Sanetti completed a one-year internship in the Clinical Research Department of a multinational pharmaceutical company, working as Study Start-up Specialist for oncology clinical trials. Her responsibilities included managing initial submissions and amendments as well as the transition of clinical studies from the former Italian portal to the new Clinical Trials Information System (CTIS), in accordance with the European Regulation (EU) 536/2014.

Ms. Sanetti joined Donawa Lifescience as a Clinical Project Assistant, supporting the project management of international clinical studies for medical devices and IVDs, being promoted to Clinical Research Associate (CRA) after only a few months. In this role, she is responsible for managing multiple study sites and conducting on-site and remote monitoring visits.

US CLINICAL SERVICES COORDINATOR / SENIOR CRA

ANA-MARIA PANAITOIU, M.D.

Ana-Maria Panaitoiu, M.D., based in Montreal, Canada, has more than 20 years’ experience in multiple therapeutic areas, but with particular expertise in cardiovascular and oncology, with drugs, medical devices and IVDs in the US and Canada.

Having received her Medical Doctor degree from the Carol Davila University of Medicine and Pharmacy of Bucharest, Romania, there followed two years’ of medical internship in Bucharest before moving to Canada where she worked for two years as a Study Coordinator at the Jewish General Hospital in Montreal. In 1997, she started to work as regional CRA for Clinimetrics Research Associates, a US CRO based in California. In this role, in addition to performing CRA tasks, she had project management responsibilities such as team management, resource allocation and visit report review. In 2002 she started to work independently and since then has had several clinical roles, including Senior Medical Officer, lead CRA, and GCP auditor for a variety of pharma, device and IVD companies.

As part of the DLC team, Dr. Panaitoiu is responsible for the coordination of international device and IVD studies taking place in North America as well as for study monitoring in US and Canada.

MANAGER, SITE ACTIVATION UNIT / CLINICAL PROJECT MANAGER / CRA

FRANCESCO ANGELINI, PhD

Dr. Angelini has a Master of Science degree in Pharmaceutical Biotechnology and a Doctorate in Life Sciences, from the Università La Sapienza in Rome.

His professional experience includes twelve years as a researcher at Università La Sapienza in the field of cardiac regenerative medicine. Most recently, he worked for three years as Clinical Study Coordinator in the Medical Oncology Unit, San Filippo Neri Hospital in Rome on behalf of Centro di Riferimento Oncologico di Aviano, and as scientific collaborator for Consorzio Oncotech (CRO).

At Donawa Lifescience Consulting (DLC) he is Manager of the Site Activation Unit, while also managing clinical projects and performing on-site and remote monitoring visits as a Clinical Research Associate (CRA).

CLINICAL PROJECT MANAGER

FRANCESCA LADISA, MSc

Francesca Ladisa has a BSc and MSc in Molecular and Cellular Biology from Università di Tor Vergata, Rome, and a second level master’s degree in Biomedical, Autoptic and Histocytotechnical Sciences from Università Cattolica del Sacro Cuore, Rome.

Ms. Ladisa’s professional experience includes internships in several scientific disciplines, including molecular biology and molecular pathology, together with management and accounting experience at a consulting company, and 2 years as a Clinical Project Administrator at Covance, the international pharmaceutical clinical research organization. As Clinical Project Administrator, her main responsibilities were to: provide support to the project team; act as the point of contact between the project team and study sites; assist Clinical Research Associates (CRAs) with on-site tasks, and provide support for Case Report Form (CRF) query resolution; set up and maintain clinical investigator files; uploading documentation to the electronic Trial Master File; arranging payments to investigational sites; manage the new study feasibility process through direct contact with Principal Investigators; and assist the Start-Up Team in submission and notification to Ethics Committee and Regulatory Authorities.

At Donawa Lifescience Consulting (DLC) Ms. Ladisa started in January 2019 as Clinical Project Assistant, and was then promoted Clinical Project Specialist and, more recently, Clinical Project Manager.  In this role, Ms. Ladisa is managing operational and financial aspects of international clinical studies with medical devices and in vitro diagnostics.

CLINICAL PROJECT MANAGER / CRA

ALFONSO GRIMALDI, PhD

Alfonso Grimaldi has a Master of Science degree in Medical Biotechnology and a PhD in Neurophysiology from Sapienza University of Rome.

His professional experience includes seven years as a researcher at Sapienza University and the Italian Institute of Technology in the field of Neuroimmunology, focusing his research on the interaction between the immune system and brain diseases. More recently, he worked for two years as a Clinical Study Coordinator in the Multiple Sclerosis Center of the Policlinico Tor Vergata in Rome.

At Donawa Lifescience Consulting, Alfonso is a Clinical Project Manager and Clinical Research Associate (CRA), supporting the company’s Clinical Unit in the project management of international clinical studies with medical devices and IVDs and performing on-site and remote monitoring visits. He is also involved in the drafting of Clinical Evaluation Reports (CERs) to meet the requirements of the Medical Device Regulation (MDR, 2017/745), including carrying out the required literature searches.

CLINICAL PROJECT MANAGER / CRA

FABIANA PROFILI, MSc

Fabiana Profili has Master of Science degrees in Drug Development and Regulatory Affairs, from Università Cattolica del Sacro Cuore, Rome, and Pharmacy, from Università La Sapienza, Rome.

Ms. Profili’s professional experience includes three years working as a pharmacist, together with an internship at the Ethics Committee of IRCCS Lazzaro Spallanzani Hospital in Rome, where her main responsibilities were to provide support in the evaluation of clinical study submissions, including studies for COVID treatment and diagnosis, and to act as point of contact between the Ethics Committee and clinical investigators.

At Donawa Lifescience, Ms. Profili’s responsibilities include clinical project management of international clinical studies with medical devices and IVDs and performing on-site and remote monitoring visits as a Clinical Research Associate (CRA).

CLINICAL RESEARCH ASSOCIATE (CRA) and CLINICAL REGULATORY ASSISTANT

DANIELE FORTUNA, MSc

Daniele Fortuna holds Master’s degrees in Clinical Research and Regulatory Affairs from the University of Ferrara, and a degree in Pharmacy from Sapienza University of Rome.

His professional experience includes five years working as a pharmacist, followed by two years as a Clinical Study Coordinator in the Gynecologic Oncology Unit at Policlinico Gemelli in Rome.

At Donawa Lifescience, Mr. Fortuna serves as a Clinical Research Associate (CRA) and Clinical Regulatory Assistant, responsible for managing multiple clinical study sites and conducting both on-site and remote site monitoring, while also supporting the submission of clinical investigation ethics committee and competent authority submissions.

US AGENT

STEVE LIEBERMAN, BS, JD

Steve Lieberman has over 40 years experience in medical device and pharmaceutical regulatory affairs. He was formerly a Vice President of Quality Assurance and Regulatory Affairs in industry, and prior to that with the U.S. Food and Drug Administration (FDA) where he held various positions in the Office of Compliance of the Center for Devices and Radiological Health. He also served FDA as a field investigator, performing international and domestic inspections of pharmaceutical and medical device manufacturers.

With a BS degree in Mechanical Engineering from Polytechnic University, Brooklyn, New York, and a Juris Doctor degree from Northern Kentucky State University, he is a Regulatory Affairs Certified Emeritus with the Regulatory Affairs Professional Society (RAPS), and a member of the Bar in the State of Ohio and the District of Columbia.

Mr Lieberman acts as the US Agent for Donawa Consulting clients, providing a US-based means for the FDA to be able to make contact with non-US manufacturers.

SENIOR QUALITY AND REGULATORY ASSOCIATE

JOHN RIGGI, BA, BS, MBA

With over 40 years’ experience in the quality and regulatory sectors of the medical device industry, Mr. Riggi’s career has spanned many industry sectors, including: ophthalmics, orthopedics, cardiac rhythm management, neurostimulation, infusion technologies, medical and dental radiation devices, and high-volume manufacturing.

Mr. Riggi is able to support DLC clients in many aspects of QA/RA implementation and management, including:

• Global QA/RA operations
• Global quality system development, implementation and assessment
• Assistance during third party audits
• Design control
• Radiation safety
• Regulatory compliance and product submissions
• Quality system training, including US, EU, MDSAP
• Corporate Compliance Assessment Programs
• ISO/CE certification / notified body interactions
• Vendor quality management
• National medical device registrations

Whether on the manufacturing floor or in front of large conference audiences, Mr. Riggi’s open and relaxed communication manner helps ensure the message is well-received and understood.

SENIOR QUALITY SYSTEM ASSOCIATE

CHERYL MCCALL, BSc

Cheryl McCall has more than 25 years of inspectional experience including 10 years with the US Food and Drug Administration (FDA), serving for four years (2013 – 2016) on the FDA Medical Device Foreign Inspection Cadre (MDFIC) and six years (2007 – 2012) as a field investigator with the FDA Los Angeles District.

During her time with the MDFIC, she planned and conducted complex regulatory inspections of more than 70 firms in over 20 countries, manufacturing high-risk medical devices. With the Los Angeles District, she performed domestic medical device inspections, as well as investigations, recall audits, and sample collections. She also conducted inspections of bioresearch monitoring studies (clinical studies), and drug, dietary supplement, and food manufacturing operations.

Before joining FDA, Cheryl’s experience includes management of a large-scale food production operation, serving as Laboratory Manager for Colorado State University/Environmental Health Services Department, managing a private consulting business, serving as an expert witness for clients in legal actions, managing food safety programs for an Alaska school district, and training for district staff in food safety topics. She also served as an Environmental Health Specialist for the Virginia State Health Department. Cheryl holds a Bachelor of Science degree in Microbiology from Colorado State University.

OPERATIONS AND CONTRACT MANAGER

SARA CATARINOZZI, BA

Sara Catarinozzi has a B.A. degree in Sociology from York University, UK, and is bilingual English/Italian. She has worked with Donawa Lifescience Consulting for over 15 years.

She manages all administrative matters for the office, including contract review, while also assisting company staff with client contacts and other support services.

If you want to reach Sara Catarinozzi, you can send an email to sara@donawa.com.

FINANCIAL SPECIALIST

MARA VALERI, BA

Mara has a degree in Political Science from the University of Rome “La Sapienza”, and a diploma in Accounting from the Technical and Commercial Institute “Gaetano Martino” in Rome. Mara works as Financial Assistant and also provides support to the DLC clinical department as Junior Clinical Assistant.