NextGen Device and Combination Product Safety
medtechnet Virtual Roundtable
Date: 12 March 2024
We are delighted to host our eighth roundtable meeting. The session will be chaired by our PV and Medtech Networks Thought Lead, Dr. Latika Sharma. The event theme and a detailed agenda will be released shortly.
For further information or to register your interest in attending this meeting please click here.
A network for Safety, Regulatory, and Labeling leaders from pharma and medical technology companies to partner and shape NextGen Device and Combination Product Safety
Having identified an opportunity for cross-network collaboration to help drive device safety processes and organization, we established medtechnet in December 2021. As an objective platform, this new and innovative network will facilitate strategic thinking and peer exchange for members.
Who should join?
Access to Key Insights - Why join ?
- Engage with your global peers
- Debate and share ideas
- Future proof your processes and systems
- Compare and improve performance
- Develop elevating connections | Actionable intelligent insights from peers to steer your efficiency
- Expanded support | Leverage content secured from expert discussions and forums
Get in touch
LATEST INSIGHTS AND TOP OF MIND TOPICS IN DEVICE AND COMBINATION PRODUCT SAFETY
- Audit and Inspection Readiness for Medical Devices – what is same, what is different?
- Software as a Medical Device (SaMD) – the new kid in the block?
- Regulations – navigating the evolving Device and Combination Product Regulatory landscape
- Vigilance – methods and tools at play
- Operating Models – now and in future
Audit and Inspection Readiness for Medical Devices – what is same, what is different?
- Different types of Audits and Inspections and their trends
- Pre and Post-audit/inspection readiness and site diagnostic review
- Key findings and mitigat
Software as a Medical Device (SaMD) – the new kid in the block?
- Categorization and potential for risks
- Cybersecurity vulnerabilities
- Risk Management programs consistent with Quality system regulations including validation, risk analysis, and servicing
- Threat modeling
Regulations – navigating the evolving Device and Combination Product Regulatory landscape
- Combination Product Regulations – Implementation, best practice, and lessons learnt
- US Regulations on devices and combination products
- Post market surveillance Under Section 522 of the Federal FDCA
- Impact and implementation of EU MDR Regulations
- Updates to processes and systems
Vigilance – methods and tools at play
- Device Surveillance using visualization tools (Tableau™)
- Device Proportional Reporting Ratio (PRR) – disproportionality measure
- Medical device trending/novel methods
Operating Models – now and in future
- Best fit organizational model
- Centralized or Distributed?
- Capacity, capability, and challenges