|
Information for Clinical Medical Device Research
Association of Clinical Research Professionals (ACRP)
ACRP allows you to explore many services for clinical research professional.
Brookwood International Academy of Healthcare Research
For information about clinical research and GCP training courses, customized in-house workshops and independently validated certification for clinical researchers, administrators and investigators look at the Brookwood International Academy of Healthcare Research website.
Canary books
Specialized clinical research and GCP books, regular newsletters and access to a complete medical bookshop can be found on the Canary Publications website - publishers of CRAdvisor and CQAdvisor and Golden GCP Rules books for Investigators and Pharmacists.
CDISC
CDISC is an open, multidisciplinary, non-profit organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development.
European Union website
Welcome to 'Europa', the European Union's server. The Parliament, the Council, the Commission, the Court of Justice, the Court of Auditors and other bodies of the European Union (EU) invite you to visit their server. Almost all EC languages available
European Competent Authorities for Medical Devices
Austria
Ministry of Social Security in English
Belgium
Directorate General of Health Protection: Medicines
Czech Republic
Medical Information Centre for European Projects in English
Denmark
The Research Ethics Committee System in Danmark in English.
Finland
Ministry of Social Affairs and Health in English
The National Agency for medicines (and medical devices) in English
France:
The French Health Products Safety Agency (AFSSAPS) with a couple documents in english. The majority is in French
Germany
Bfarm in English
DIMDI (German Institute of Medical Information and Documentation) on medical devices in English.
Greece
The National Organization for Medicines (EOF) is a public entity of the Greece Ministry of Health. EOF mission is to ensure public health and safety with regard to (amongst others) medicinal products for human and medical devices, marketed in Greece. In English.
Hungary
Authority for Medical Devices in English
Ireland
Irish Medicines Board Medical Device Website. This site has been developed by the Medical Devices Department of the Irish Medicines Board (IMB) to illustrate the services that are in operation with regard to Medical Devices. It is also to facilitate the registration of medical devices used within Ireland.
Italy
Department of Italian Health Ministry only in Italian
Netherlands
The Central Committee on Research Involving Human Subjects (known by its Dutch initials, CCMO) oversees medical research involving human subjects in the Netherlands. Informative site including a list of certified Medical Ethics Committees (in English).
Ministry of Health in English.
Norway
Ministry of Health in English
The Norwegian Board of Health including good (English) information on the Norwegian Regulations concerning Medical Devices. The Board of Health is an independent technical agency, and is administratively part of the Norwegian Ministry of Health. The Board of Health provides the Ministry with technical advice and information
Poland
Ministry of Health and Social Security in Polish
Portugal
The National Pharmacy and Medicines Institute is a Government agency accountable to the Health Ministry. The objective is to monitor, assess and regulate all activities relating to human medicines and health products for the protection of Public Health. Summary in English, majority of website in Portuguese.
Slovenia
Ministry of Health in English
Spain
Ministry of Health and Consumers in English
Sweden
Medical Product Agency in English
The National Board of Health and Welfare with all English documents on their website
Switzerland
SwissMedic the Swiss Agency for Therapeutic Products on medical devices in English
UK
Medical Device Agency of the Department of Health. Very informative website of the MDA, the UK's Competent Authority for Medical Devices
Standardization Bodies
ISO A network of national standards institutes from 145 countries working in partnership with international organizations, governments, industry, business and consumer representatives. A bridge between public and private sectors.
International Conference on Harmonization (ICH) of Technical Requirements
|
