Free QServe Webinar - 10 Facts You Need to Know Now to Prepare for the IVDR
This 1-hour webinar will provide the answers to the pressing questions Senior Level Executives are asking as IVD manufacturers are preparing for the next major impact to EU Regulation and how this will affect the entire industry in 2022.
With the IVDR drawing near, Sue Spencer will cover the 10 KEY facts that executives need to know now and how it will affect your entire organization. The introduction of the IVDR is described as a cultural shift because it impacts so many parts of the business. If you think this only impacts quality and regulatory you need to listen to this webinar! Being prepared early could save you a lot of resources and money and the presentation will answer some very tough questions.
Register here.
New Medical Device Regulatory Intelligence Service from Emergo
The Regulatory Affairs Management Suite (RAMS) digital platform for global market access enables manufacturers to manage their device registrations and certifications across multiple countries and gain valuable market insights from a single, fully automated system. The software includes new tools and capabilities to support streamlined RA/QA operations.
Key capabilities include:
· Registration Tracker and Regulatory Updates
· Regulatory Overview Reports for 22 Markets
· All of Emergo’s Regulatory Process Charts
· Copies of global regulations already in Emergo’s website, plus expanded list of regulations and added markets
· FDA 510(k) review time calculator and classification support, which extracts real-time information through connection with the FDA’s website
· Regulatory FAQs to answer common and not so common questions and issues
Note: To Activate all features, make sure to enable them after signup by visiting the RAMS Marketplace. For questions, contact bdwest@ul.com.
JOB SHADOWING PROGRAM
Do you think you would like to share a day with a regulatory student, showing them how you do your job?
Do you want to show a student ways to think through challenges, adapt to the new ISO rules, understand different country regulatory changes, or understand new biologics as examples.
We are actively reaching out to match the newest members of our profession at the University of Washington’s BRAMS program with host ORCA members. Spend a day together.
This is an opportunity available to current members only.
Please contact Elizabeth Cross Nichol for more information or click on the buttons below to fill out an information or application form.
Host Information Form
Observer Application Form
ORCA NEEDS YOUR HELP!
Volunteers are vital to ORCA’s success. Volunteers assist ORCA with its monthly programs, plan those programs and solicit speakers, develop and implement marketing efforts and membership drives, serve on its Board of Directors, and provide a wide range of volunteer services that help make ORCA a meaningful and useful resource for its members. Visit our Volunteering page to find out more about how you can help.
The FDA and Prescription Drugs: Current Controversies in Context
Understand how the FDA regulates pharmaceuticals and explore debates on prescription drug costs, marketing and testing.
New Device Advice e-Learning Tool
The Medical Devices Bureau has announced the launch of a new Device Advice: e-Learning tool “Understanding How Medical Devices are Regulated in Canada – Premarket Regulations”. This learning module is intended to help stakeholders better understand what the premarket regulatory requirements are for the importation or sale of medical devices in Canada.