Where are you on the road to EU-MDR compliance?
October 11, 2016
Qserve is a global regulatory consulting firm, specializing in EU-MDR compliance. Dr. Gert Bos, EU-MDR specialist and leading Qserve’s efforts around the EU-MDR states: “Training on the significant changes in the EU legal framework is essential in 2017 to prepare manufacturers for effective implementation the coming years”
For 2017, Qserve has designed a monthly step-by-step training program to implement EU-MDR compliance. The implementation model that we use in running MDR projects is applicable for small, mid-size, and multi-national manufacturers. In the training sessions this implementation model will be delivered via use of a ‘hypothetical’ medical device manufacturer. Throughout the sessions, this model will be the key element to explain implementation of EU-MDR compliance. Industry speakers and Notified Bodies will present experiences, and participate in interactive workshops and panel discussions.
Participation in all 10 sessions will ensure your company has the tools to implement EU-MDR compliance within your organization, in a practical approach. Alternatively, you can choose to select topics or join specific sessions of particular interest to your company.
Flexible options for your company, team, or individual subject experts:
Sessions will follow this format:
- Presentations by Industry leaders and Notified Bodies
- Lunch and interactive workshop training
- Panel discussion, followed by question and answer session with speakers
Data and subjects:
16th of January: Steps to implement EU-MDR Compliance program
20th of February: Clinical (CER) MEDDEV 2.7.1. Rev 4
20th of March: Pre-Market
20th of April: QMS Alignment
15th of May: Supply Chain
26th of June: Technical file set up
18th of September: Clinical: PMCF
16th of October: Combination products
23th of November: IVD
11th of December: Wrap up & Notified bodies
- Full Passes may be purchased by an organization. A Full Pass on the company name allows attendance by multiple subject experts within your organization. (one per session)
- Multiple passes per company are possible. Please contact firstname.lastname@example.org for further details.
- Single session passes may be purchased day of event (subject to late registration fee) €400/session
- If you missed a topic and wish to view a session, please contact email@example.com for specific requests.
- Invoices will be send out in January 2017
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