ISO – Page 2 – Eisner Safety Consultants

What Standards Apply to My Device? Podcast #383

𝗪𝗵𝗮𝘁 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗔𝗽𝗽𝗹𝘆 𝘁𝗼 𝗠𝘆 𝗗𝗲𝘃𝗶𝗰𝗲? Podcast with one of the best MedTech podcasters Etienne Nichols – Greenlight Guru’s very own

𝗞𝗲𝘆 𝗧𝗼𝗽𝗶𝗰𝘀:
• Why standards like IEC60601 are crucial for medical device development
• Steps for identifying proper standards for your product
• How to integrate standards into your design process
• Mistakes & consequences of ignoring standards
• Tools for staying updated on changing standards & regulations
• How startups can navigate standards with limited resources

IEC 60601-1 4th Ed Initial Launch: Positive Impacts Healthcare Standardization

Last week, 29 Apr – 3 May 2024, marked a significant milestone for the advancement in the world of patient safety and healthcare. The IEC TC 62/SC 62A convened its IEC 60601-1, 4th edition project kick-off meeting at AAMI in Arlington, Virginia. More than 200 experts from all corners of the globe attended in person, contributing to an inspiring and impactful week-long meeting.

FDA’s ASCA Program Becomes Permanent

Great News!!!! Effective 19 September 2023 FDA’s Accreditation Scheme for Conformity Assessment (ASCA) Program converted from a pilot program after 3 years to a permanent program, the agency announced. The transition is authorized under the Medical Device User Fee Amendments

Standards & Regulatory Update – Medical Electrical Devices – Article

In the June issue of InCompliance Magazine I provide advice in an article on how to remain current on medical electrical device standards (including those in development) and regulatory guidance documents. I start up at the International level (IEC & ISO)

Free Webinar – What You Need to Know About Medical Electrical Standards Updates

Jon Speer, founder and VP of QA/RA @ greenlight.guru (moderator of the webinar) and I, Leo the “IEC 60601-1 guy” Eisner, Principal Consultant of Eisner Safety Consultants, will be presenting a webinar “What You Need to Know About Medical Electrical Equipment