Articles & Video
Preparing your organisation for MDSAP: Australia, Canada, Japan, Brazil - WHITEPAPER
This whitepaper details how your organisation can prepare for the Medical Device Single Audit Program (MDSAP) in Australia, Canada, Japan and Brazil.
MedTech Report 2020: EU MDR and IVDR Compliance
Download the MedTech Report 2020 on EU MDR and IVDR Compliance, based on 265 survey responses from industry insiders.
Article 117: Preparing Drug Device Combination Product Manufacturers for the EU MDR - WHITEPAPER
Article 117 EU MDR: This whitepaper offers advice to prepare drug device combination product manufacturers for the new regulations.
Manufacturing Incident Reports (MIR) under the EU MDR - WHITEPAPER
This whitepaper explores Manufacturing Incident Reports (MIR) for medical devices under the EU MDR.
Life Sciences in 2030 Survey: Complete to win a 2-day conference pass
We are a conducting a huge survey of life sciences professionals around the world on how the industry will look by 2030. Complete it here to get early access to the final report.
Regulatory challenges for Software as Medical Device (SaMD) and AI
We asked six medical device industry experts about the regulatory challenges of Software as Medical Device (SaMD) and Artificial Intelligence.
EU MDR: Assessing the impact on biocompatibility testing
This whitepaper examines the regulatory changes brought by the EU MDR around medical device biocompatibility testing, and how compliance will affect common practice.
MedTech TV: EU MDR and IVDR implementation challenges
At MedTech Summit in Brussels we interviewed two industry insiders on the hottest topics facing the industry for MedTech TV - watch the full interviews here.
EU MDR: New expectations for clinical evaluations and investigations - WHITEPAPER
In May 2020 the EU MDR officially replaces the EU MDD. This whitepaper assesses new expectations for clinical evaluations and investigations under the EU MDR.
What's shaping the future of biotech?
Could the November presidential election impact drug prices? What does the investment landscape look like for this year? Download the free article pack to discover how financial and biotech experts tackled these questions and many more at Biotech Showcase™ and Digital Medicine & Medtech Showcase.
Understanding how ISO 10993-17 and ISO 10993-18 connect - WHITEPAPER
This whitepaper explores parts 17 and 18 of ISO 10993, how they relate, and considerations for industry.
Comparing EU and FDA approaches to regulating MedTech software and AI - WHITEPAPER
This whitepaper explores the different EU and FDA approaches to regulating MedTech software and AI.
Regulatory development opportunities for global harmonisation of eSubmissions
What's delaying the global harmonisation of eSubmissions for market authorisation? This whitepaper examines the latest developments and ongoing challenges.
MedTech 2020 Survey: EU MDR and IVDR Compliance
Complete our MedTech survey on EU MDR and IVDR Compliance to be in with a chance of winning a 2 day conference pass to MedTech Summit.