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TOPIC
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Title
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Author
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Safety & Performance
Requirements
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General Safety and Performance Requirements (Annex I) in the New medical Device Regulation
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BSI
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Technical Documentation
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Technical Documentation and Medical
Device Regulation – A Guide for Manufacturers to Ensure Technical Documentation Complies with EU Medical Device Regulation 2017/745
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BSI
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MD Operators
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Importers, distributors and assemblers
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BSI
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Responsible persons
The role of the person responsible for regulatory compliance
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BSI
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Authorized representatives
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BSI
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Responsible persons, authorized representatives and the new EU Regulations
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BSI
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MDR IVDR Guidance
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Planning for implementation of the European Union Medical Devices Regulations – Are you prepared?
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BSI
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The proposed EU regulations for medical and in vitro diagnostic devices – An overview of the likely outcomes and the consequences for the market
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BSI
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MDR & IVDR –
Roles in the Regulatory System
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BSI
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MD
Classification
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MDR Classification
Annex VIII
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BSI
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Classification changes
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BSI
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IVD Classification
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Explaining IVD classification issues
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BSI
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UDI
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UDI compliance
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BSI
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What you need to know about the FDA’s UDI system final rule
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BSI
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Sterilization
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Sterilization – Regulatory requirements and
supporting standards
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BSI
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MDR Route
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MDR Conformity Assessment Routes Guidance
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BSI
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MDR Documentation
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MDR Documentation Submissions Best Practice Guidelines
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BSI
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MDR Mapping Guide
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BSI
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Medical Devices Regulation Impact on Resources
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BSI
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Medical Devices Regulation What you need to know
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BSI
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IVDR Documentation
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IVDR Documentation Submissions Best Practice Guidelines
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BSI
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IVDR Update Webinar
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BSI
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MDR Transition
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MDR Readiness Review
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BSI
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Comparison of the annexes of the European Medical Devices Directive (93/42/EEC) and the Medical Devices Regulation ((EU) 2017/745)
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BSI
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Comparison of the articles of the European Medical Devices Directive (93/42/EEC) and the Medical Devices Regulation ((EU) 2017/745)
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BSI
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Relationship between the MDR and the former MDD
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BSI
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IVDR Transition
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IVDR Readiness Review
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BSI
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Developing and maintaining a quality management system for IVDs
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BSI
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MDR FAQ
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MDR Frequently Asked Questions
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BSI
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IVDR FAQ
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IVDR Frequently Asked Questions
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BSI
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Notified Body
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BSI Guide to Notified Body
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BSI
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ISO 13485:2016
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ISO 13485 Frequently Asked Questions
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BSI
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The differences and similarities between ISO 9001:2015 and ISO 13485:2016
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BSI
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ISO 13485 – The proposed changes and what they mean for you
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BSI
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Risk Management
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Risk management for medical devices and the new BS EN ISO 14971
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BSI
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MEDDEV 2.7.1 Revision 4
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The Top Ten Changes in MedDev 2.7.1 Rev 4
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BSI
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MDR Implementation
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How to prepare for and implement the upcoming MDR – Dos and don’ts
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BSI
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IVDR Implementation
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How to prepare for and implement the upcoming IVDR – Dos and don’ts
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BSI
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Cybersecurity
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Cybersecurity of medical devices -Addressing patient safety and the security of patient health information
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BSI
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Clinical Investigation and Evaluation
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Medical device clinical investigations – What’s new under the MDR?
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BSI
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Clinical Evidence Requirements – Key Changes and Clarifications
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BSI
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Labelling
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MDR – Labelling Requirements
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BSI
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Post Market
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The Post-Market Priority
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BSI
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Post-market surveillance
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BSI
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Effective post-market surveillance – Understanding and conducting vigilance
and post-market clinical follow-up
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BSI
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How to get to the market and stay there!
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BSI
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Enhanced PMCF
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BSI
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Surveillance & Vigilance
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Do you know the requirements and your responsibilities for medical device vigilance reporting?
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BSI
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The European Medical Devices Regulations
What are the requirements for vigilance reporting and post-market surveillance?
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BSI
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Other documents
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Recent Advancements in Al – implications for medical device technology and certification
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BSI
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Digital maturity in an age of digital excitement
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BSI
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Machine Learning AI in Medical Devices
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BSI
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Nanotechnology
What does the future look like for the medical devices industry?
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BSI
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The impact and potential for 3D printing and
bioprinting in the medical devices industry
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BSI
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Engaging stakeholders in the home medical device market
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BSI
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Negotiating the innovation and regulatory conundrum
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BSI
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The growing role of human factors and usability engineering for medical devices
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BSI
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BSI Webinar – Person Responsible for Regulatory Compliance
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BSI
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Nanomaterials and medical device regulations
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BSI
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