The revision of both standards was published by the International Organization for Standardization in September 2015 with a three-year transitional period.
Transitioning to ISO 9001:2015 & 14001:2015
Brexit & EU product legislation: What to expect?
Undoubtedly, the departure of the UK from the European Union (EU) will cause a major shift in the industry sector and the related EU product legislation.
On 19th January 2018, the European Commission published an official Notice to Stakeholders [Withdrawal of the United Kingdom and EU rules on company law] presenting the new rules on company law in reference to the withdrawal of the UK from the European Union.
Obelis Scientific Department Officially Launched!
On 1st September 2016, Obelis officially launched a new department within the company structure – the Scientific Department. It makes up part of the Compliancy Unit and complements the pre-existing Regulatory Affairs & Quality Assurance Department. Read more
Brexit – What happened?
On June 23rd 2016, 52% of UK citizens voted in favour of the ‘Brexit’: Britain-Exit of the European Union. This vote comes following much political disagreement, primarily surrounding the open borders policy (free movement) of the EU. The legal process for the UK to leave the EU will be initiated only once the Prime Minister of the UK informs the Council of the European Union of this decision, which will initiate the negotiations between the EU & the UK based on Article 50 of the Treaty of Lisbon.
Nomination for Best Service Exporter Company 2015
Obelis has been nominated for the Best Service Exporter Company 2015 in the Brussels Capital Region!
ISO 9001:2015 – A New Approach!
After over three years of revision work and nearly 95 participating and observing countries, the new ISO 9001:2015 was published on September 23, 2015.
This new approach has been released to respond to the latest market trends and will bring the quality standards into the 21st century.
Revised animal tissue standard could be available by the end of 2015
MHRA issues a Draft Guidance on the Re-Manufacturing of Single-Use Devices
10th Round of Negotiations – TTIP
The 10th round of negotiations for The Transatlantic Trade and Investment Partnership (TTIP) was concluded on July 17th 2015, in Brussels. During the negotiations, the parties discussed all three pillars of the TTIP – namely: 1) market access, 2) the regulatory component and 3) the so-called ‘rules’ issues. According to the Statement of the EU chief negotiator – Ignacio Garcia Bercero, much of the discussion focused on regulatory affairs with significant convergence between the parties. Read more
French Court of Appeal clears Notified Body Liability in PIP breast implant case
ISO 9001:2015 – What You Need to Know
Why a new ISO 9001?
All ISO standards are reviewed every five years to establish if a revision is required to keep it current and relevant for the marketplace. The future ISO 9001:2015 will respond to the latest trends and be compatible with other management systems such as ISO 14001. Read more
TTIP and SMEs: what potential?
The Transatlantic Trade and Investment Partnership (TTIP) has significant potential for small and medium sized enterprises, according to a report released by the European Commission. It presents the results of a survey of small and medium-sized enterprises (SMEs) carried out in 2014 on challenges they face when exporting to the United States. It also uses newly available data to look at the scale of exports by EU SMEs to the United States. Read more
Obelis s.a. becomes PCPC International Associate Member
Obelis s.a. is Celebrating its 25th Anniversary!
This year on Friday, 27th of September, Obelis s.a. is celebrating its 25th anniversary !
I am proud and honored to have reached this unique milestone in the company’s history.
Created in 1988, Obelis s.a. has encountered along the way successes, difficulties and challenges leading all to the company’s current position in the European regulatory niche – one of the largest European regulatory centers in the EU.
How far we have come! Working with companies from over 50 Non-European countries is what makes our company’s profile exclusive, our vision to expand and our leadership approach unique.
Though many milestones have been reached along the 25 years – development of services covering almost all “New Approach” directives, EAAR membership, ERPA creation, OLOS, OIO and experts networks development, ISO 9001:2008 & 13485:2003 certifications… and many others – we are not stopping here. We are looking ahead towards challenging projects as we are constantly focusing on anticipating and exceeding our clientele and future clientele’s service requirements.
All could not be possible without my children beside me, their support, contribution, believe and execution of the company’s policies, vision and mission.
As CEO, I am looking forward to an exhilarating future: a future for which I am grateful to the company’s Management (Mr. Doram Elkayam & Ms. Sandra Ferretti), the company`s Board of Directors and our devoted team members, who are all to be held responsible for Obelis’ successes and upcoming achievements.
Thank you all for your continuing support, Happy Anniversary to all of us!
Celebrating today 24 Years in Business
Today, 24 years ago, on September 27th 1988, Obelis s.a. was created by Mr. Gideon Elkayam.
Words from Obelis C.E.O. Mr. Gideon Elkayam :
“Looking backwards and into the future, I was convinced many years ago that alone, I will not be able to make it. Therefore I tried and managed to sway my children, Doram Elkayam & Sandra Ferretti to join me and take this ride together, I am blessed by God, having them rising up to the challenge and together making Obelis what it is today. We also give thanks to all the Obelis team (Employees & Interns) short or long term, each one contributed to the global success.
Finally, I am proud being part of this adventure, proud of my family, children, experts, employees, Interns and all which gave me so much support, trust and no less important friendship. Thank you all for the nice words, your friendship and contribution to this life achievement called “Obelis”. Thank you for who you are and for sharing with us all your outstanding knowledge, your belief in our company’s mission, vision and objectives, it made it all possible.”
Obelis Featured on Important Suppliers Directory
Obelis European Responsible Person Center (O.E.R.P.C.) was recently featured on personalcaresuppliers.com, an important USA portal dedicated to suppliers of products in the field of personal care. The website run by Personal Care Products Council, which is “the leading national trade association representing the global cosmetic and personal care products industry” presents Obelis’ high standard services for cosmetics related affairs in the European market:
- EU Responsible Person
- EU Cosmetic Notification
- Cosmetic Product Information File
- EU Safety Tests
- EU Safety Assessment
ECORE Seminar by Obelis to be Launched at Cosmoprof North America
ECORE is Obelis’ exclusive brand-name for seminars dedicated to the European Regulations concerning cosmetics. Under this name Obelis European Responsible Person Center (O.E.R.P.C.) has organized several events all over the world and this July, 23rd Obelis will hold an insightful seminar during one of the most important industry events: Cosmoprof North America, in Las Vegas.
Medical Devices Workshop in Sao Paulo by EG Mont & Obelis
With a collaboration of over a decade, OBELIS and its Representative in Brazil, EG MONT, are proud to launch a resourceful workshop on the 23rd of May, 2012 in Sao Paulo.
As a special support to manufacturers exhibiting or visiting Hospitalar 2012 the Workshop will cover current issues and processes on the implementation of EU directives, EU harmonized standards and detailed steps to be taken by manufacturers in order to attain the CE marking affixed on their medical devices.
Already at its 6th edition, this insightful workshop has proven to be a strategic move for a many professionals in several domains within the medical device industry looking to further expand their business to the European Market and other international markets by having their products CE certified.
The workshop will cover critical topics, such as:
- Role of the Notified Bodies ;
- Role of the European Authorized Representative ;
- Medical Device classification and Declaration of Conformity;
- National Device Registrations ( Italy, Portugal & France);
- GMDN code verification;
- The new MEDDEV 2.5/10 – guidance document on the Authorized Representative;
- Free Sales Certificate by a European Authority;
Obelis Obtains ISO 13485:2003 Certification
In addition to the ISO 9001:2008 certificate obtained since May 2001, Obelis European Authorized Representatives Center (O.E.A.R.C.) has obtained its ISO 13485:2003 certification in April 2012, attesting to the high level of quality services provided to its clients.
ISO 13485:2003 sets prerequisites for quality management systems, evidence to a company’s capacity to manufacturer medical devices and/or provide related services aimed at consistently meeting customer and regulatory requirements.
Obelis Featured on Important US Community of Cosmetics Manufacturers
Obelis was recently chosen to be featured as an international partner by one of the most dynamic web communities for small cosmetics manufacturers in the USA, indiebeauty.com.
The website aims to equip manufacturers with the motivation and tools to build a successful business through tele-seminars, publications, mentoring and coaching, plus regulatory resources. In this respect, Obelis European Responsible Person Center was chosen as a trusted provider of services for those businesses looking to expand and export to European Union market.
Obelis can present businesses with a large array of services, such as:
- Free product classification,
- Information on the EU Cosmetic Regulations (EC 1223/2009 and Cosmetics Directive 76/768/EEC),
- Guidance on cosmetic safety assessment,
- Guidance on Product Information File (PIF),
- Cosmeto-vigilance reporting and complaint handling coordination,
- EU pre-market notification and many other.
Obelis presenting at US Commercial Services Webinar
On February 29th, 2012, the U.S. Commercial Service will broadcast a webinar aimed at facilitating the U.S. cosmetic industry’s better understanding of the new European Cosmetic Regulation (1223/2009/EC) to repeal the EU Cosmetics Directive (76/768/EEC) on July 2013.
Obelis C.O.O, Doram Elkayam, will join the discussion on the new mandatory provisions of the EC Regulation, with a dedicated presentation on the EU Responsible Person and the New European Cosmetic Product Notification Portal (CPNP).
The webinar will cover central aspects of the new EU Cosmetics legislation, such as:
- General provisions of the cosmetic regulation with a comparative analysis on the safety requirements between the Cosmetic Directive 76/768/EEC and the New Cosmetic Regulation EC 1223/2009;
- The EU Responsible Person: roles and responsibilities;
- The New European Cosmetic Product Notification Portal (CPNP);
- The EU Safety Assessment (Toxicological Assessment): provisions & requirements;
- With a time for FAQs on labeling & language requirements, Nano-Materials, Product Information File, Safety Tests and more.
Join the webinar, Wednesday, February, 29, 2012 (17:00 pm CET) to discover everything you need to know about the new EU Regulations on Cosmetics!
Indie Beauty Network (IBN) Tele-Seminar a Great Success
The Introduction to EU Cosmetic Regulation tele-seminar took place on October 27th 2011, in association with the Indie Beauty Network (IBN) & Obelis European Responsible Person Center (O.E.R.P.C.).
The tele-seminar consisted of a brief overview of Obelis background, experience and expertise, the “main players” involved in EU cosmetic compliance, the steps to compliance, Product Information File, the necessity of appointing a professional “Responsible Person”, and much more. This was followed by an extended, open question and answer period. Members unable to attend the live seminar submitted questions to Donna Maria (IBN Founder) by email, Facebook, and Twitter.
Initial Cosmetic Webinar to Indie Beauty Members
After much anticipation, Obelis will be presenting an Introduction to the European Cosmetic Regulation in association with Indie Beauty Network to IBN Members placing Cosmetic products on the market on October 27th, 2011.
Do you know the basics of selling in Europe? Join in on the conversation.
EU Regulation & CE Marking Workshop in Sao Paulo, BRAZIL
Obelis is pleased to announce that EG MONT, Obelis’ Official Representative in Brazil, in association with HI-POWER, MEDLAB, and CENIC will be conducting a workshop in Sao Paulo, Brazil concerning the application and revisions of the CE marking as pertaining to the current European Union Directives. This workshop will focus on the CE marking as it applies to Medical Devices, In-Vitro Diagnostic Devices and how the Waste Electrical and Electronic Equipment (WEEE) and the Restriction of Hazardous Substances (RoHS) Directives influence such devices to be placed onto the European Market.
Obelis Now Included as Business Service Provider by US Trade & Commerce Department
Obelis S.A. is happy to announce that it has been officially added to the US Trade & Commerce website as a Business Service Provider and Advisor.
The US Trade & Commerce department is a branch of the United States Commercial Service (CS) which is the trade promotion arm of the U.S. Department of Commerce’s International Trade Administration and helps U.S. companies succeed in markets around the world.
Obelis is now listed as a Business Service Provider for Product Standards, Testing, and Certification in the European Union. As such, Obelis brings its 20 years of experience in European Authorized Representation, Regulatory knowledge and expertise in European Directives, and consultation services to a wider American audience. This allows for small and medium-sized American businesses to find Obelis more quickly and to speed up their entry into the European Market.
Obelis Launching EUCORE Workshop: Safety Assessment (Toxicological Assessment)
EUCORE 5 is organized by Obelis European Authorized Representative Center (O.E.A.R.C.) together with the Federation of Israeli Chambers of Commerce and the full support, guidance & involvement of the Israeli Ministry of Health.
Obelis International Offices Convention
Obelis International Offices (OIO) Background
Launched in 2010, Obelis’ International Offices (O.I.O.) is a global network aimed at creating a strong & dedicated Network of International Obelis Offices. The offices will serve local clients with the same high standards, qualities and values provided by our home office.
Representatives Convention 2010
Representatives Convention 2010
EUROMED: Obelis International Offices Convention
Obelis has launched its new International Offices and will be hosting EROMED at its home offices in Brussels, Belgium.
EROMED is a 2 day workshop exclusively aimed at Obelis International Offices (O.I.O) network – providing regulatory updates, knowledge & expertise and promoting Obelis European Authorized Representative Center (O.E.A.R.C.) services in their global markets.
The Workshop is organized by Obelis s.a European Authorized Representative Center & GiDoS s.p.r.l in association with INTERTEK. Presentations will be given by experts in their fields about the latest developments in the European Regulatory framework concerning Medical Devices, In-Vitro Diagnostics, Cosmetic products, and others, with a special emphasis on the recent implementations of the 2007/47/EC, as of March 21st, 2010 (MDD), and the EC 1223/2009, as of November 30th 2009 (Cosmetics).
EROMED workshop in Sao Paulo a Success!
EROMED, held on 24 May 2010, in Sao Paulo, Brazil was a great success thanks to our cooperation with EG MONT of Brazil, and HI-POWER, a Brazilian company representing the Czech Notified Body ITC in Brazil.
The workshop involved over 40 participants, including a representative of ABIMO, the Brazilian Association of Medical Devices Manufacturers .
EUCORE Workshop: GMP – EN/ ISO 22716
The EN/ISO/ 22716 guidelines are intended to provide guidance regarding Good Manufacturing Practices for cosmetic products. These guidelines have been prepared for consideration by the cosmetic industry and take into account the specific needs of this sector. These guidelines offer organizational and practical advice on the management of the human, technical and administrative factors affecting product quality.
New Obelis U.S. Offices
We are proud to announce the opening of Obelis’ offices in the United States located in Salt Lake City, Utah as of January 7th, 2010.
As one of the largest regulatory centers in Europe providing CE marking advisory and European Authorized Representative services, Obelis management decided to launch operations in the U.S.
For over 20 years, Obelis has provided a gateway to the EU market for Non-EU manufacturers from over 35 countries around the world. Obelis has had their sights set on the U.S. market for years running now. C.O.O. Doram Elkayam hopes that with the expansion of the U.S. offices, Obelis will continue to grow and succeed as they have in the past.
Through offering EU compliance services for products, Obelis hopes to raise the level of involvement in the European market for U.S. manufacturers and to further facilitate the services provided by Obelis to such manufacturers wanting to penetrate the European market. Thus, creating for them a European regulatory strategy while supporting them throughout the process and acting as their Authorized Representative in Europe at all times as required by the European Directives and applicable European Regulation.
The activities will include but are not limited to: client recruitment and client relationship management, Exhibition presence, seminar & workshop planning and execution with an administrative support on regulatory affairs between the manufacturer and Obelis’ Brussels, Belgium headquarters.
The contact for the U.S. offices will be:
USA Marketing & Sales Manager
Tel : +1 (801)-590-3572
Fax: +32(0)2 7326003
M: +1 (801)-819-5191
EUCORE Workshop: The New European Regulation on Cosmetics
Professional Seminar on: The New European Regulation on Cosmetics
The EUCORE seminar is a unique opportunity for importers of cosmetics to be exposed to European demands by European experts (e.g. representatives of the Belgian Ministry of Health and from the British Toxicology Lab INTERTEK) in light of the Israeli Ministry of Health will for alignment of the Israeli Law with the European regulation.
As such, Obelis European Authorized Representative Center (O.E.A.R.C) in association with the Israeli Chamber of Commerce, the Manufacturers Association of Israel, The Israeli Society of Chemists and the Cosmetics Division at the Ministry of Health have taken it upon themselves to organize this special event.
Obelis launches “EROMED” Workshop
EROMED is a 2 day workshop exclusively dedicated to the NEW European regulation imposed by the 2007/47/EC. The Workshop is organized by Obelis s.a European Authorized Representative Center & GiDoS sprl in association with MDC Medical Device Certification GmbH a German Notified Body, the Israeli Chamber of Commerce and the Israeli Export Institute. You will be taught by experts in their fields about the latest developments in the European Regulatory framework concerning Medical Devices in reference to the upcoming implementation deadline of March 21st 2010 by the 2007/47/EC.
Obelis launches “EUCORE” Workshop
Obelis European Authorized Representative Center (O.E.A.R.C ) in Cooperation with the Manufacturers Association of Israel (the Cosmetic Department) and the Israeli Ministry of Health (Pharmaceutical Division) are proud to introduce the “EUCORE” Workshop aimed at the “New European Cosmetic Regulation – Provisions and Implementation”.
The workshop will be a one-time opportunity dealing with the requirements of the European Cosmetics regulation by European Experts in light of the Israeli Ministry of Health desire to harmonize and align its regulation with the European regulation.