Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X

Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X

Don’t make the 5 costly mistakes companies make with Medical Device Standards. Learn from the IEC 60601 Guy himself.:

Late Identification of Applicable Standards: Leads to expensive redesigns and delayed timelines

Ignoring Expert Standards Guidance: Results in regulatory rejections and costly resubmissions

Unprepared Risk Management File for Testing: Risks unnecessary costs due to lack of strategic planning for compliance.

Unprepared Regulatory Submissions: Leads to costly setbacks and market-entry delays

Underestimating Education and Training: Creates knowledge gaps, increasing errors and compliance risks.

ISO 20417, 2nd DIS Breaking News from Tokyo Meeting πŸ“£πŸ“£

ISO 20417, 2nd DIS Breaking News from Tokyo Meeting πŸ“£πŸ“£

πŸ‘‰ ISO TC 210 WG2 met in Tokyo, Japan πŸ‡―πŸ‡΅ on 4 – 5 March 2025. πŸ‘‰ WG2 meeting focused primarily on resolving the National Committees (NCs) comments received on the ISO/DIS 20417, 2nd ed. Changes proposed: πŸ‘‰ Add reference

10x Humanizing MedTech: Breaking The Mould For Conferences

10x Humanizing MedTech: Breaking The Mould For Conferences

Join us for the fifteenth 10x Medical Device Conference on May 7 to 8, 2025 – Hyatt Regency Newport Beach, CA What’s 10x 2025 about you ask? Join experts Carrie Britton, Matthias Fink, Sean Smith, Jan Gates, Angelina Lisandrelli, Jose

MedTech Leading Voice 100 2025 Yearbook – Great Resource Tool!!

MedTech Leading Voice 100 2025 Yearbook – Great Resource Tool!!

This is an amazing resource that MedTech Leading Voice has put together and is free to download. ‘This isn’t a “best of” list – it’s a guide to people worth following … Β It’s a guide to 100 individuals worth following

IEC 60601 Updates: What MedTech Need to Know for 2025 and Beyond Podcast

IEC 60601 Updates: What MedTech Need to Know for 2025 and Beyond Podcast

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. We unpack the upcoming revisions to IEC 60601, 4th ed.,