For manufacturers located in Israel with an interest in introducing their products (Medical Devices, In-Vitro Diagnostics, Cosmetics & Others) onto the European Market, the Israeli Branch Manager is responsible for all contact and service. 

Mr. Hemi Zimmerman has served in this position since the Israeli Branch was established in 2005. As Branch Manager, responsibilities include marketing and sales activities, managing company events and assisting clients located in Israel.

The Israeli Branch is aimed at successfully managing the following activities:

• International Exhibitions
• Potential Follow-up
• Management Meeting Agenda
• Workshops & Seminars
• Market Presence & Development

• Administrative Support with Israeli Clients

For manufacturers located in the United States with an interest in introducing their products (Medical Devices, In-Vitro Diagnostics, Cosmetics & Others) onto the European Market, the USA Branch Manager is responsible for all contact and service. 

Ms. Stacy Edelen has served in this position since the USA Branch was established in 2009. As Branch Manager, responsibilities include marketing and sales activities, managing company events and assisting clients located in the United States.

The USA Branch is aimed at successfully managing the following activities:

• International Exhibitions
• Potential Follow-up
• Management Meeting Agenda
• Workshops & Seminars
• Market Presence & Development

• Administrative Support with USA Clients

Mr. Webster managed MDCI Ltd’s medical device consulting and European Authorised Representative business in the UK from 1997 until 2010.  He has over 40 years of quality assurance, regulatory and management experience.

Mr. Webster served for many years as European Director of Regulatory Affairs for Boston Scientific based in Paris and previously for Meadox Medicals Inc. based in UK. 

During the writing of the Medical Device Directive, he was responsible for technical affairs at EUCOMED representing the medical technology industry in Europe, and chaired the committee writing the Essential Requirements in Annex I of the Directive.  Mr Webster has chaired the committee responsible for writing the European standards on labelling and symbols used with medical devices (CEN/CLC/TC 3/WG 1) since its creation.  He regularly speaks at professional conferences on all aspects of medical device quality and regulatory compliance

He holds a higher degree in Chemistry from the University of Newcastle upon Tyne, is a Chartered Chemist and a member of the Royal Society of Chemistry (C.Chem, M.R.S.C.), holds a Diploma in Management Studies from the University of East Anglia, is Certified as a Quality Engineer by the American Society of Quality, is a Fellow of the Regulatory Affairs Professional Society (RAPS), serves on the European Operating Committee and is Regulatory Affairs Certified (RAC).

John Webster has acted as Treasurer of the European Association of Authorised Representatives (EAAR) and currently holds the post of Secretary.

Dr. Peter N.  Ruys, an expert consultant in International Medical Device regulations. Founder of the Notified Body KEMA Quality in The Netherlands(1992-2004) ,one of the leading members in the initial implementation of the European Directive for Medical Devices, holds degrees in physics and chemistry from the University of Utrecht.

Dr. Ruys served many years as a Certification Manager for medical devices in the notified body. He was executive director with Qserve consultancy (2004-2008) and in 2008 launched his own consultancy company .

Dr. Ruys is active in the Dutch Standardization Institute NEN for normalization activities.

Dr. Ruys acts as non executive director and Senior Regulatory Expert for Obelis s.a..

With over 10 years experience in quality assurance and EU regulations, the C.C.O. is responsible for overseeing and managing compliance issues within the organization and ensuring internal and client compliancy.

The responsibilities of the position include leading enterprise compliance efforts, designing and implementing internal controls, policies and procedures to assure compliance with applicable local laws, Member States, EU laws, EU regulations and third party guidelines, managing audits and investigations into regulatory and compliance issues, and responding to regulatory requests for information from clients and regulatory bodies.

Notification & registration department

• MDD Class I notifications
• Clinical Investigation Notification
• Other Device registrations in EU Member States
• Cosmetic products notifications
• Other notifications
• Free sales certificates
• Trade mark registration

ISO Quality Management System

Internal auditing
• Documents and procedures QA and management

Regulatory department

• Classification issues
• Regulatory researches and compliance
• Human resource compliance and administration compliance
• Education programs

For any administrative matter (Agreements, terms and conditions, Invoices, Payments, Database and overall client relations & services) Obelis’ C.O.O. is the address. Involve Mr. Doram Elkayam on all matters allowing Obelis to insure the best service possible provided to you.

Mr. Doram Elkayam acts as the Obelis C.O.O., encompassing the following Obelis departments and activities:

Marketing ,Sales & Business development Department :

• Overall Obelis Marketing presence – Exhibitions & Events.
• Offers and Agreements.
- Potential client follow-up.
• Business development – Lead Generation & New services.

Administration Department:

• Overall Client service (Opening and closure of Client dossier).
• Invoicing, payments & overall client relations.
• Coordination between Obelis departments to ensure client satisfaction.
• Obelis online client Database developments, administration and functionality.
• Obelis’ facilities and branches.

International Relations Department:

• Obelis One Link One Solution – Obelis’ world network of regulatory advisors.
• Obelis Representatives - Obelis’ world network of international representatives.
• Worldwide Associates, Collaborators and VIPs.

Mr. Gideon Elkayam has acted as Obelis’ C.E.O since Obelis’ creation on September 27, 1988. Through Mr. Gideon Elkayam’s hard work, leadership, code of ethics and always present drive for excellence, Obelis has managed to achieve important mile stones through the years.

Mr. Gideon Elkayam has managed to achieve important mile stones through the years such as:

• 1996: Launching of the “European Authorized Representative Center” (O.E.A.R.C).
• Ensuring the quality of services by completing ISO certification for Obelis as one of the few E.A.Rs which is ISO certified in accordance to the profession of a European authorized representative.
• 2003: Transforming Obelis to an active member in the E.A.A.R (European Association of Authorized Representatives) and as such an active member in the ever changing world of the policy making in the European commission (the E.A.A.R has been recognized by the EU commission and is an official stake holder).
• Transforming Obelis to an active member within the EU commission major committees (Medical Device Vigilance committee and IVD Technical committee)- providing Obelis clients and collaborators with the directions of the Commission before hand.
• 2005: Opening of Obelis’ Israeli Branch.
• 2006: Creation of the “Obelis Group” with a new management chart including all Obelis s.a. projects.
• 2008: Creation of GiDoS s.p.r.l www.gidos.net
• 2008: milestone- 20 years in business.

Alongside some social and educational milestones such as:

• 1998: Launching of the Obelis Internship Program (O.I.P.) - Obelis recognized the mutual benefits of providing fresh young minds with unique opportunities if being part of an exciting and energetic working environment within Obelis; as such Obelis has been rewarded over the years by many worldwide Universities – the program has been a success story for hundreds of interns for the last 10 years – and will continue to be as such for many more.
• 2006: Launching the Obelis Worldwide Educational Activities (Workshops & Seminars) – working with National organizations such as Chambers of Commerce, Export Institutes, Standard Institutes, Manufacturer’s associations, Associations for Quality and others.