I will do medical device fda submissions and cers

M
manjesh_0292
M
manjesh_0292
Manjesh
do medical device fda submissions and cers
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do medical device fda submissions and cers
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do medical device fda submissions and cersdo medical device fda submissions and cersdo medical device fda submissions and cers

About this gig

Regulatory Submission:

Prepare and submit regulatory applications to obtain necessary approvals for medical device marketing. This includes:

- Preparing and submitting 510(k), PMA, or De Novo applications to the US FDA and Health Canada.

- Preparing and submitting CER and CEP to Notified Bodies

- Obtaining approvals from other regulatory agencies globally (e.g., CDSCO in India)

- Ensuring compliance with regulatory requirements and guidelines

- Responding to regulatory queries and addressing deficiencies


Clinical Evaluation Report (CER) Writing:

I summarize the clinical evaluation of a medical device, demonstrating its safety and effectiveness. It involves:

- Reviewing clinical data and literature

- Evaluating device performance and safety

- Assessing benefits and risks

- Concluding device safety and effectiveness

- Preparing a comprehensive report meeting regulatory requirements

Get to know Manjesh

Manjesh

Your Medical Device, Our Regulatory Expertise! Data entry done right!

  • FromIndia
  • Member sinceApr 2025

  • Languages

    English
Expertise in Medical Device Submissions and Medical Device Regulatory. I have a good hands-on experience in analyzing data for clients, including creating reports and visualizations using AI. Expertise with the MS-Office tools such as Excel, Word, and Power-Point. Provide accurate and efficient data entry services with high accuracy and speed, and can handle complex data entry tasks, including data cleaning, data validation, and data formatting using AI tools that provides more accurate results.

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