EAAR is the home for the professional European Authorized Representative organizations serving the Medical Device and In-Vitro Diagnostic manufacturers in accordance with the European Medical Device Directives.
http://www.eaarmed.org/
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EAAR | eaarmed.org Reviews
https://eaarmed.org
EAAR is the home for the professional European Authorized Representative organizations serving the Medical Device and In-Vitro Diagnostic manufacturers in accordance with the European Medical Device Directives.
eaarmed.org
EAAR | About
http://www.eaarmed.org/about
European Commission Working Groups. EC WG – CIE. EC WG – EUDAMED. EC WG – IMDRF. EC WG – IVD Technical. EC WG – MDEG on B&C. EC WG – N&ET. EC WG – NB-MED. EC WG – Software. EC WG – Vigilance. EVENTS & IMPORTANT DATES. Proudly powered by WordPress. Design by : White Line.
EAAR | Mission Statement
http://www.eaarmed.org/mission-statement
European Commission Working Groups. The European Association of Authorised Representatives (EAAR) is an alliance of European Authorised Representatives who have joined forces to promote professional conduct and competence. EAAR members possess a shared vision of enhancing the quality of European Authorised Representation and aim to provide an understanding of European Authorised Representatives’ responsibilities to other stakeholders. EC WG – CIE. EC WG – EUDAMED. EC WG – IMDRF. EC WG – MDEG on B&C.
EAAR | 22.04.2013 – EAAR Assembly Meeting [London, UK]
http://www.eaarmed.org/22-04-2013-eaar-assembly-meeting-london-uk
European Commission Working Groups. 22042013 – EAAR Assembly Meeting [London, UK]. First to access the content! Categories: EAAR Assembly Meeting. Larr; Previous Post. Next Post →. EC WG – CIE. EC WG – EUDAMED. EC WG – IMDRF. EC WG – IVD Technical. EC WG – MDEG on B&C. EC WG – N&ET. EC WG – NB-MED. EC WG – Software. EC WG – Vigilance. EVENTS & IMPORTANT DATES. Proudly powered by WordPress. Design by : White Line.
EAAR | 26.03.2014 – EAAR Assembly Meeting [Paris, France]
http://www.eaarmed.org/26-03-2014-eaar-assembly-meeting-paris-france-2
European Commission Working Groups. 26032014 – EAAR Assembly Meeting [Paris, France]. First to access the content! Categories: EAAR Assembly Meeting. Larr; Previous Post. Next Post →. EC WG – CIE. EC WG – EUDAMED. EC WG – IMDRF. EC WG – IVD Technical. EC WG – MDEG on B&C. EC WG – N&ET. EC WG – NB-MED. EC WG – Software. EC WG – Vigilance. EVENTS & IMPORTANT DATES. Proudly powered by WordPress. Design by : White Line.
EAAR | Members
http://www.eaarmed.org/members
European Commission Working Groups. Email: t.pennings@cepartner4u.com. Donawa Lifescience Consulting s.r.l. Medical Device and QA Services Ltd. Medical Device Safety Service GmbH. Medical Technology Promedt Consulting GmbH. Email: medpass.ar@medpass.org. Obelis s.a. European Authorized Representative Center. Qarad European Regulatory Services. Tecno-Med Ingenieros S.L. EC WG – CIE. EC WG – EUDAMED. EC WG – IMDRF. EC WG – IVD Technical. EC WG – MDEG on B&C. EC WG – N&ET. EC WG – NB-MED.
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Events and News | AbNovo
http://abnovo.eu/events-and-news
8230; comprehensive solutions for medical device manufacturers. Articles and presentations by Mika Reinikainen. Intellect Clinical Safety Symposium II: Software as a Medical Device (developments & risk management) – 14 July 2011, London, UK. 26 July 2011, 5:00 pm. Software as a medical device – regulatory aspects. Informa’s Medical Device Post Market Surveillance and Vigilance 16 – 17 February 2011, Maritim proArte Hotel, Berlin, Germany. 4 January 2011, 7:59 pm. Legal fundamentals of PMS. The basics of ...
Authorised Representation | AbNovo
http://abnovo.eu/services/authorised-representation
8230; comprehensive solutions for medical device manufacturers. Articles and presentations by Mika Reinikainen. Our unique partnership approach to authorised representation means that we:. First get to know your staff, products and business objectives. Stay in touch: we don’t just collect invoices, we talk to you actively. Are pro-active: we look out for warning signs in the regulatory environment and keep you informed. Strive to maintain you in good regulatory health; we are regulatory professionals.
Our People | AbNovo
http://abnovo.eu/our-people
8230; comprehensive solutions for medical device manufacturers. Articles and presentations by Mika Reinikainen. Mika Reinikainen, LL.M., MBA is the founder and Managing Director of AbNovo Ltd. He received his Master’s Degree in Law from the Institute of the Law of Peace and Development, University of Nice, France. He obtained his Master’s Degree in Business Administration (MBA) from the Wharton School, University of Pennsylvania, Philadelphia, USA. Comments are closed Trackback. The Organisation for Prof...
The basics of authorised representation | AbNovo
http://abnovo.eu/services/authorised-representation/the-basics-of-authorised-representation
8230; comprehensive solutions for medical device manufacturers. Articles and presentations by Mika Reinikainen. The basics of authorised representation. Why do you need an authorised representative in the European Union? If you are a manufacturer outside the European Union (EU) and sell your products in the EU, the law requires you to have an authorised representative in the EU. What is an authorised representative? European law defines an authorised representative as somebody who:. AbNovo’s unique appro...
One Stop Shop | AbNovo
http://abnovo.eu/services/one-stop-shop
8230; comprehensive solutions for medical device manufacturers. Articles and presentations by Mika Reinikainen. AbNovo’s unique one stop shop service provides a single gateway to key service providers spanning full product and business life cycles. Among these are:. Product design and development. Full CE marking in Europe. US marketing clearance (PMAs and 510(k)s). Quality assurance systems (setting up and auditing). Clinical trials and evaluation. Access to grants and venture capital. EAAR – Euro...
Intellect Clinical Safety Symposium II: Software as a Medical Device (developments & risk management) – 14 July 2011, London, UK | AbNovo
http://abnovo.eu/2011/07/26/intellect-clinical-safety-symposium-ii-software-as-a-medical-device-developments-risk-management-14-july-2011-london-uk
8230; comprehensive solutions for medical device manufacturers. Articles and presentations by Mika Reinikainen. Laquo; Informa’s Medical Device Post Market Surveillance and Vigilance 16 – 17 February 2011, Maritim proArte Hotel, Berlin, Germany. Intellect Clinical Safety Symposium II: Software as a Medical Device (developments & risk management) – 14 July 2011, London, UK. 26 July 2011, 5:00 pm. Software as a medical device – regulatory aspects. Articles and presentations by Mika Reinikainen. RAPS –...
Global Medical Device and Diagnostic Packaging Labelling and Compliance, Munich, 24-26 January 2011 | AbNovo
http://abnovo.eu/2011/01/04/global-medical-device-and-diagnostic-packaging-labelling-and-compliance-munich-24-26-january-2011
8230; comprehensive solutions for medical device manufacturers. Articles and presentations by Mika Reinikainen. I n f o r m a L i f e S c i e n c e s ’ 5 t h A n n u a l conference on The Medical Device Directive And The Future Recast, 26-27 January 2011, Renaissance Hotel Brussels, Belgium. Global Medical Device and Diagnostic Packaging Labelling and Compliance, Munich, 24-26 January 2011. 4 January 2011, 6:05 pm. Comprehensively Addressing All Compliance Requirements with a Special Emphasis. I n f o r ...
Services | AbNovo
http://www.abnovoconsulting.net/services
8230; comprehensive solutions for medical device manufacturers. Articles and presentations by Mika Reinikainen. Do you need top level regulatory help? Are you concerned about future regulatory requirements? Do you want to reduce regulatory risk? Do you have a compliance problem? Do you need a due diligence audit? Check out our regulatory consulting services. Are you looking for an authorised representative in Europe? Check out our user friendly and pro-active authorised representative service. I n f o r ...
What you should be concerned about. | AbNovo
http://abnovo.eu/services/regulatory-consulting/what-you-should-be-concerned-about
8230; comprehensive solutions for medical device manufacturers. Articles and presentations by Mika Reinikainen. What you should be concerned about. Compliance with the new requirements for medical devices (Directive 2007/47/EC) became mandatory on 21 March 2010. Do you have the consolidated version of Directive 93/42/EEC. Medical devices) and 90/385/EEC. Active implants) that contain the new requirements? See what standards are suspect here. Explain the new requirements. Help you to implement solutions.
Workshops and training | AbNovo
http://abnovo.eu/services/workshops-and-training
8230; comprehensive solutions for medical device manufacturers. Articles and presentations by Mika Reinikainen. Conferences are an expensive way to train your personnel and do not focus on your real needs. Why not get the experts to come to you? We can tailor workshop contents to your needs and bring some of the best experts in the field to teach and train your staff on your own premises. Basic European regulatory requirements for medical devices. General requirements for drug/device combination products.
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As of 21 March 2010. EU/EC European Authorised/Authorized Representative. Must be designated by a non-EU manufacturer of medical devices as required by directive 2007/47/EC, are you ready? Medical Devices and IVD. In Vitro Diagnostic Medical. Other EU/EFTA authorities by world-leading CE Marking. Specialists based in London/UK. Click here to get FREE Guide. You export to Europe? UL mark; China Compulsory Certification- CCC Mark. China RoHS compliance and solutions, etc. How can Wellkang help you? Wellkan...
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European Commission Working Groups. The home for the professional European Authorized Representative organizations serving Medical Device and In-Vitro Diagnostic manufacturers in accordance with the European Medical Device Directives. Members of the European Association of Authorized Representatives (EAAR). Provide services under the following European Directives :. Medical Device Directive (MDD) 93/42/EEC. In-Vitro Diagnostic Directive (IVDD) 98/79/EC. The European Association of Authorised Representati...
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