Current/Future Events - Event View

This is the "Event Detail" view, showing all available information for this event. If the event has passed, click the "Event Report" button to read a report and view photos that were uploaded.

Return to Grid View Show Search

Today

Webinar - Prepare Yourself: EU MDR Implementation in 8 Months!

When:

Thursday, October 24, 2019, 8:45 AM until 10:00 AM

Where:

Webinar - link will be emailed to attendees 2 days prior to the meeting.
Contact us at info@orc

Event Contact(s):

ORCA Admin

Category:

Webinar

Registration is closed

RSVP by Wednesday, October 23

Meetings and webinars are scheduled on Pacific Standard Time or Pacific Daylight Time, whichever applies.

Please make sure that the following email address is in your Safe Sender list: mailer@mail2.clubexpress.com. System messages like meeting announcements, registration confirmations, webinar login instructions as well as certificates of attendance are sent directly from this email address.

You will receive an email 2 days prior to the meeting date with the webinar login instructions or after payment is processed if registering closer to the meeting date. If you don't receive the instructions within this time frame, please contact us at info@orcanw.org as soon as possible.

PAID FEES ARE NON REFUNDABLE.

For webinar events, payment is REQUIRED at the time of registration.

Capacity:

100

Active Member (Regular, Student, Government)

No Fee

Non-Member

$60.00

Add to my Calendar

The link to the webinar is intended for the registered person ONLY and should not be shared.
All attendees MUST be registered.
This webinar will be recorded.

TOPIC: Economic Operators & PMS

TOPIC DESCRIPTION:
Economic Operators
How can large manufacturer handle the various verifications the manufacturer, importer and distributor need to perform and avoid duplication? (related to MEDTECH Europe document)

Sharing practical examples
- Is "placing on the market" and "making available" triggered by PHYSICAL ownership AS WELL as legal ownership?
- Are 3rd Party logistics providers (e.g. Healthlink, Rhenus, UPS) who are Fulfillment Service Provders also distributors?
- Challenges with the point of "placing on the market" for capital equipment (and devices which must be installed) - who then is the importer? Who is the distributor?
- Should Economic Operators be managed through the Supplier Management process within the QMS (ISO 13485:2016 clause 7.4)?

PMS
PMS under MDR - Practical implementation
- PSUR creation
- Timing/content (including usage, patient population)
- Getting the Information needed
- Defining roles and responsibilities between departments/functions
- PROCESS for Assessing/Analyzing the data and drawing conclusions, holistically, across various data sources
- Connecting with other plans and reports in the QMS
- Timing and connection with CER (per class)

Vigilance reporting
- New definitions
- New timelines
- Managing info from EOs
- Changes to process/software
- Reporting thru Eudamed

Maintaining responsibilities after product obsolescence (implants, capital equipment, and in general)

SPEAKER: Keith Morel, Qserve Group US

SPEAKER BIOGRAPHY: Keith Morel, VP of Regulatory Compliance at Qserve, leads the San Francisco office. He handles all technical consulting as well as business development and sales.

He assists clients with all their worldwide medical device approval/registration/maintenance needs, be they strategic or tactical, in all of our six key business areas
(i) Regulatory Affairs/Compliance
(ii) Clinical Evaluation and CRO services
(iii) Quality Assurance
(iv) Training
(v) Auditing (internal, supplier and mock third party) and
(vi) Global Product Registration (>40 countries to date).

He has worked in the medical device industry since 2000. Prior to joining Qserve, he was Senior Director or Regulatory Compliance at Accuray (a radiation oncology medical device manufacturer).

WHO: Clinical, regulatory, quality, manufacturing and legal

Attendance at this meeting may be applied as 1.5 points towards RAC re-certification