Competent Authorities for Medical Devices CAMD explaining us the PRRC role with @Thierry Sirdey #medicaldevices #teamprrc2023 #regulatoryaffairs #eumdr
Author: m-coles
Continued recognition of UKAS
In a significant development for international accreditation post-Brexit, the Italian Council of State has upheld the validity of certifications accredited by UKAS. This decision marks a crucial juncture in maintaining the integrity of international standards amidst political changes. The ruling affirms that UKAS-accredited certifications remain…
COMMISSION DELEGATED REGULATION
The EU has just issued a new regulation relating to the UDI of contact lenses. This is a follow-up form the previous MDGC guidance. COMMISSION DELEGATED REGULATION (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council,…
Brand reputation
I’m always amazed why companies with a Brand reputation still risk the business in this way. https://www.ethicaltrade.org/blog/bbc-findings-call-question-boohoos-ethical-commitments
Certificate of Assurance
We are pleased to announce we have reconfirmed our compliance with the Cyber Essentials scheme for another year. Well done, team!
Trial Master File
What is a trial master file? If you’re a medical device manufacturer, chances are, you’ll need to conduct one or more clinical trials before you can prepare your product to go to market. It’s not just the trial itself that matters, though—the way you record…
ISO 9001 Certification
FREE ISO 9001 Certification: Exciting Collaboration Opportunity with International Associates (IA) 🤝 International Associates is proud to have been accredited by UKAS for ISO 13485 medical devices for the last 7 years, making partnerships a seamless process. We have a robust presence in the social…
13485 AUDITOR COURSE EVENT
Mon, Jan 22, 2024, 2:30 PM – Wed, Jan 24, 2024 10:00 PM ISTISO 13485 AUDITOR COURSE Birmingham, GB https://www.linkedin.com/events/iso13485auditorcourse7115354105262272512/
ISO13485 Training Course
ISO13485 Training Course We are running a 3-day training course aimed at Internal Auditors and Quality Management System Auditors to upgrade their knowledge to the ISO 13485 standard. This course will teach students the principles of ISO 13485:2016 and how to use tools, as well…
The HPRA will hold a Custom-Made Device (CMD)
The HPRA will hold a Custom-Made Device (CMD) webinar in October 2023. The webinar is scheduled as a virtual event and will be hosted on the Microsoft Teams platform. The webinar will give an overview of the Medical Devices Regulation (MDR) and how it applies…
