Profile Details

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★★★★★

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USD 40 /hr

★★★★★

☆☆☆☆☆

Hire Kavita S.

India

USD 40 /hr

Experienced Medical Device Regulatory Affairs professional

Profile Summary

We are a team of experienced regulatory compliance expertise for Medical Devices and In-Vitro diagnostic devices across all risk classes. We have prior experience in writing CERs for Medical Devices with specialties in cardiovascular, spine, orthopedics, and general surgery. Our website: https://dceservices.in/

Subject Matter Expertise

• ★ European Medical Device Regulation (MDR)
• ★ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ★ Clinical Evaluation Reports (CER)
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Medicine
• ☆ Medical Sciences
• ☆ Product Compliance
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews

Services

• Writing
• Research
• Consulting

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Feasibility Study, Systematic Literature Review

Consulting Scientific and Technical Consulting

Work Experience

Sr. Executive Marketing & Human Resources

DCE Services

August 2019 - Present

Education

Post Graduate Diploma in Management (PGDM)

Institute of Management Technology, Ghaziabad

September 2016 - May 2018

M.Tech Biomedical

Vellore Institute of Technology

September 2013 - May 2015

Certifications

• Certification details not provided.