Skip to main content
search
Category

Industry Newsletters Regulatory Affairs Newsletter Archive

Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

BSI IVDR Documentation Submission guide

BSI have added a section on AI/ML documentation to their guidance on technical documentation submission: https://www.linkedin.com/posts/bsi-medical-devices_bsi-medical-devices-ivdr-documentation-activity-7325889686483202048-X1A1?utm_source=share&utm_medium=member_android&rcm=ACoAAAAeH9EBFpe2TIKx6c7gKShKVeAb46UjtpM
Ben Kemp
May 15, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

New Resource: Framework for Direct Patient Input in RWD

NEW FRAMEWORK Advancing Direct Patient Input in Real-World Data and Evidence (RWE) Generation   MDIC’s Science of Patient Input program has released a new framework to help the medical device community strengthen patient perspectives in real-world data (RWD) and real-world evidence (RWE) generation. The Direct Patient Input in Real World Data Framework is designed to guide manufacturers in collecting, using,…
Ben Kemp
April 11, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

🔹IFCC Global MedLab Week 2025🔹IFCC Accreditation Programme🔹IFCC-EFLM EuroMedLab Brussels 2025

The GMLW 2025 is approaching! It will take place from April 21 to 27, 2025, with the theme "Labs Save Lives." Visit the official website at https://globalmedlabweek.org/ and follow our social media profiles @globalmedlabweek to stay updated on all initiatives and watch videos and contributions from this year's participants. Your involvement will help increase the campaign's visibility and contribute to…
Ben Kemp
April 11, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

TGA UDI requirements

TGA UDI requirements coming into effect         Complying with the Unique Device Identification requirements for medical devices | Therapeutic Goods Administration (TGA) Complying with the Unique Device Identification timeframes for medical devices | Therapeutic Goods Administration (TGA) Australian UDI Data Dictionary | Therapeutic Goods Administration (TGA) Australian UDI Bulk Upload Template | Therapeutic Goods Administration (TGA) Australian…
Ben Kemp
April 11, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

A reckoning for global shipping – New Reuters Events White Paper

Of interest if you rely on global supply chains (very difficult not to, in todays world), and rely on global shipping for importing or exporting your goods: Next week, the International Maritime Organization (IMO) will meet to decide the future of global shipping – and the stakes couldn’t be higher. If IMO leaders agree forward mid-term measures, including a financial…
Ben Kemp
April 4, 2025
Close Menu