From Cork – Ireland
Lives in the Penedès region near Barcelona, Spain

Academic Background: Degree in Electrical and Electronic Engineering
B.E. (Elect.) from the National University of Ireland at UCC, Cork, 1991
Partner at Tecno-med Ingenieros S.L. (1995 – present)
Specialist in medical devices and medical technology regulatory affairs, technical consultancy and quality systems applied to medical technology.
More information at www.tecno-med.es www.tecnologias-sanitarias.com

Dario Pirovano has over 30 years experience in Medical Technology, as designer and regulatory affairs expert. He worked for 7 years as R&D and regulatory manager with Ohmeda in Milan signing some 20 project for anesthesia machines, lung ventilators and neonatal care devices. He worked for 4 years within the Commission of European Communities where he contributed to the drafting and negotiating 90/385 /EEC and 93/42/EEC directives. He was then director of Medical Technology Consultants Europe from 1991 to 1995. In 1995 he founded Pirovano Management SPRL, a consulting firm advising manufacturers, Notified Bodies and authorities in regulatory matters related to Medical Technology.  Dario can be considered the historical memory of the development of medical devices regulation in Europe Dario holds a Doctorate in Engineering from the Politecnico di Milano. Being Italian mother tongue, Dario is also fluent in English and French with basic knowledge of German and Spanish. Since 2002 Dario is Senior Regulatory Affairs Adviser for MedTech Europe on a consulting basis.

Helene Quie has a degree in Science specialised within cell biology from the University of Odense. Helene has 25 years of experience within the pharma and medical device industries working for inter alia Cook Medical A/S,
H. Lundbeck A/S, AMBU A/S and Millimed A/S. Her primary expertise is within the clinical and regulatory areas such as device development, quality management, project management, clinical trial execution, market access
and general management. In 2006 she founded Qmed Consulting as a private consultancy company providing services within medical device development and clinical trials.

Merlin Rietschel is currently the leading coordinator of activities related to Notified Bodies at MedTech Europe. He previously held the position of Senior Manager in MedTech Europe’s International Affairs department. He joined Eucomed (now MedTech Europe) in January 2011 and worked for the Regulations and Industrial Policy department. He also held various positions within international pharmaceutical companies (Bristol-Myers Squibb and GlaxoSmithKline Biologicals) and also worked at the European Medicines Agency (EMA) in London, UK.

Merlin holds a Master’s degree in pharmaceutical science. A German and French national, he is also fluent in English.

Co-owner and Principal consultant

Maurizio Suppo (born 1960, Italian citizen) obtained his Ph.D. in molecular biology from the University of Turin (Italy) in 1985. Maurizio has more than 34 years of experience in the field of regulatory affairs and quality systems in the In-Vitro Diagnostic industry. He held executive positions at Sorin Biomedica (now DiaSorin), Becton Dickinson, Dade Behring and Siemens Healthcare. He has been the Director of the European Diagnostic Manufacturers Association (EDMA) and, in that role, he represented the IVD industry position in the drafting of the European IVD Directive 98/79/EC. His knowledge and experience in RA&QS go beyond the European borders.

Trained ISO-9001 & 13485:2016 auditor Dr. Suppo is also an expert MDSAP auditor with more than 500 MDSAP audit hours as a lead auditor.

Maurizio Suppo joined Qarad in July 2012 and became partner and co-owner in January 2016. He is a regular speaker and chairman at international conferences and published more than 20 articles in the specialized press. He is fluent in Italian, English, French with a good knowledge of Spanish.

Gavia is Unit Manager for Devices Regulatory Policy at the Medicines and Healthcare products Regulatory Agency (MHRA). She is responsible for the oversight of policy and strategy in relation to the devices regulatory framework in the UK. This includes providing regulatory policy advice and guidance regarding the implementation and interpretation of the current and future medical devices legislation. She has also been responsible for supporting the Agency with EU Exit preparation for medical devices.

Gavia has been with the MHRA for over four years, previously holding the posts of Project Manager for the Devices Regulations and Senior Regulatory Policy Manager within the Devices Division. Since joining the Civil Service, she has worked in a number of other Government departments, including in the Cabinet Office and the Ministry of Justice, advising Ministers on strategies to deliver key Government priorities and policy objectives.

Erik specialises in EU and national legal and regulatory issues relating to medical devices. He is an expert in life sciences regulation at EU and Dutch level.  Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorete-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms. Erik is a prolific writer on medical technology and (EU) regulation.

After more than 10 years in industry, working for 2 medical devices manufacturers, Klaus-Dieter Ziel was one of the founding members of MEDCERT in 1993. Since that time he is the Managing Director leading MEDCERT´s business. This means, that he is dealing with and familiar with the CE marking of medical devices for more 25 years.

Deputy Head of Unit, European Commission, Directorate General for Health and Food Safety (SANTE)
Medical Devices and Health Technology Assessment Unit, Belgium

Erik joined the cosmetics and medical devices unit of the European Commission in 2012 to lead the implementation of the PIP Action plan, followed by the negotiations on the new Regulations. Erik is responsible for several EU working groups (such as MDCG, previously MDEG), heads the EU delegation to the international regulatory cooperation in IMDRF and is coordinating the cooperation with national Competent Authorities in the CAMD framework. He is a negotiator of trade agreements in the two sectors.
Erik holds a Master degree in law from the University of Uppsala, Sweden, followed by positions in law courts and co-ordination of preparations for the EU-membership in Swedish ministries and agencies. Since joining the European Commission in 1997 Erik has mainly dealt with policies relating to the single market for goods (such as general product safety) as well as strategic policy planning and finance.

Amanda Maxwell is Medtech Regulatory Affairs Editor at Medtech Insight.

She has some 30 years’ experience in reporting and providing analysis on developments in the field of medical technology regulatory affairs, with particular focus on the current and future EU regulations for medical devices, IVDs and device/drug combination products.

Amanda also has experience in providing medtech regulatory strategy consultancy services, and is a frequently invited speaker and chair at EU meetings on Medtech regulations and drug/device combination regulatory issues.