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OCRA - Do you CER?
Wednesday 08 August 2018, 04:00pm - 07:00pm
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 Orange County Regulatory Affairs Discussion Group (OCRA)
Invites You To an Evening Workshop 

Do You CER?

OCRA 8-8-18 Event Photo

 

Regulatory agencies worldwide are elevating their acceptance standards for technical documentation to achieve CE marking and maintain product commercialization. Per the 2017 EU Medical Device Regulations, a Clinical Evaluation Report is required for ALL product classifications.

 

Come to the OCRA CER Workshop for answers to these Burning Questions!

Why do I have to CER?
What is required / Who is responsible?
How do I demonstrate Safety and Performance?
What are the Clinical Data Requirements?
How do I choose a Conformance Route?
How do I perform a Literature Review?
Who has to review and approve the CER?
What are my Notified Body expectations? 

3 Hours Towards Your RAC Recertification
All OCRA Meetings Qualify For Recertification Hours
 

OCRA 8-8-18 photo 2

Program Host:
Aiying Sun, Director, Quality Compliance, Masimo
 

Program Manager and Speaker:
Eri Hirumi. Regulatory Affairs Specialist 

Speaker:
Allison Oliva, RAC, Clinical and Regulatory Consultant.CER Author/Reviewer

 

See event flyer for additional details, directions and registration form for offline use.

Synopsis:
Clinical Evaluation Reports (CERs) have become a critical element in technical documentation packages. Clinical data, , literature review, product complaints, and adverse event reporting are key elements of a CER and ensuring constant information capture is becoming increasingly burdensome. This workshop provides an opportunity to identify CER requirements by product classification, draft a CER outline, and learn how to select and include appropriate supporting data.

Who should attend?

  • Regulatory and Quality professionals at all levels working in the Medical Device Industry.
  • Product Development Specialists designing and delivering medical products to
  • Technical Writers and Clinical Evaluators authoring Clinical Evaluation Reports.
  • Strategic planning and commercialization specialists

 

 

Location  Masimo, 52 Discovery, Irvine, CA 92618
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