Resources
ABC can work with any of these partners to ensure you are offered the best solution for your needs. We will tailor our service to incorporate any third-party input that is necessary, meaning you benefit from a vast wealth of knowledge without the hassle of project managing multiple companies.
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The Medical Device Company
MDC has over 30 years of experience and specialist knowledge in the design, production and management of Medical Devices and Equipment. They can help translate concepts into successfully manufactured and commercially viable products. |
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THAY Medical
THAY Medical focus on future proofing medical products by minimising medical errors. They can assist with incorporating best practices in the fields of human factors, usability, biomechanics, anthropometrics, ergonomics and user experience (UX). |
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Cognidox
ABC are in partnership with Cognidox. Some med tech eQMS options are clunky and prescriptive in the way they operate. Cognidox is adaptable, scalable, and designed to flex with your needs. |
Other Useful Links
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UK
MHRA - Medicines and Healthcare products Regulatory Agency The UK Competent Authority Europe Revision of the Medical Device Directives - European Commission Here you will find copies of the current Directives for IVDs and Medical Devices, as well as information regarding proposed transition to new regulations and the current status in the European Parliament Directives & Standards Comprehensive listing of EU directives and the new harmonised standards Reference documents and MEDDEVs - European Commission Listing of current recognised “EN” standards and Industry Guidance documents covering the entire range from Vigilance through to Clinical Evidence Contacts within the National Competent Authorities - European Commission Contact points and addresses of European National Competent Authorities Notified Bodies - European Commission Comprehensive listing of all Notified Bodies in Europe EU rules for medical devices Details and implementation of new regulations for IVDs and Medical Devices across the European Union |
USA & Canada
FDA (Food & Drug Administration) The starting point for the FDA website - a very useful resource with a wealth of relevant guidance FDA Guidance Documents New searchable index for all official FDA Guidance Documents Canadian Medical Devices Regulations Regulations & Classifications for Canada Global Unique Device Identification Database (GUDID) Access to information submitted to the FDA about medical devices with Unique Device Indentifiers (UDI) International ARTG (Australian Register of Therapeutic Goods) Therapeutic Goods Administration and Regulations for Australia Japanese Ministry of Health, Labour and Welfare English language version of the MHLW website International Medical Device Regulators Forum Following on from the GHTF, this is a valuable resource for guidance documents on a wide variety of subjects and reflects much of the current thinking of regulators in key markets |