certainly Why do you need a UK Responsible Person in Great Britain? If you are a manufacturer placing medical devices on the British market but are located outside Great Britain (England, Scotland and Wales), the law requires you to have a UK Responsible Person (UKRP) here. What is a UK Responsible Person? The UK Responsible Person …
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Abnovo’s network of partners can provide a wide scope of services. General services Compiling technical documentation Organising clinical trials and writing clinical evaluation reports Setting up and running quality systems Specialised services Authorised representation in the European Union Regulatory assistance and authorised representation in Switzerland Dealing with NHS procurement in the United Kingdom
Presentation on: Software as a medical device – regulatory aspects
Pre-Conference Workshop Tuesday 15 February 2011 on: Development in Field Safety Corrective Action (FSCA) – Recalling Presentation on: Legal fundamentals of PMS Post Conference Workshop Friday 18 February 2011 on: PMS Master Class: How to take it further? Conference program
Presentation on: Definition And Classification Of Medical Devices Conference program
Workshop on: Comprehensively Addressing All Compliance Requirements with a Special Emphasis on Labelling and Packaging Issues to Ensure Implementation of an Effective and Efficient Post-Market Surveillance (PMS) Strategy Presentation on: Exploring the Fundamentals of European Labelling and Packaging Requirements for Medical Devices: A Comprehensive and Up to Date Introduction Conference program
Articles When doctors are replaced by artificial intelligence,,,, TOPRA Regulatory Rapporteur, October 2021 Authorised representative concerns – deadline 2020, BSI Compliance Navigator for Medical Devices, 2 August 2019 An overview of new and emerging medical technology, TOPRA Regulatory Rapporteur, April 2019 From the Directives’ ERs to the new Regulations’ GSPRs: revolution or evolution in the …
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Conferences can be an expensive way to train your personnel and they often 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 …
Advice on various regulatory issues to a manufacturer of cochlear implant. Advice to a manufacturer of a cardiovascular implant after a total recall of the product in one EU Member State and successful negotiations with the National Competent Authority to accept the re-launch of the product. Review of and corrections to the bilingual Instructions for …
To contact Abnovo please use the contact form or you can find additional details below. AbNovo Ltd Suite 115 Wey House 15 Church Street Weybridge Surrey KT13 8NA United Kingdom Telephone: +44 7798 631554 E-mail: enquiries@abnovo.eu