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OCRA - Clinical Evaluation Reports (CER) and Product Classification Workshop With Two Added Speakers to Focus on Australia and China
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 

 

Clinical Evaluation Reports (CER)
and Product Classification Workshop
With Two Added Speakers to Focus on Australia and China



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 Clinical Evaluation Reports (CER) and Product Classification 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 

Speakers:
Allison Oliva, RAC, Clinical and Regulatory Consultant.CER Author/Reviewer
Luis Jimenez, Vice President, Business Development, Brandwood Biomedical
Grant Bennett, CEO, Brandwood Biomedical 

 

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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