Profile Details

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USD 75 /hr

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Hire ASHU A.

India

USD 75 /hr

Quality and Regulatory Affairs professional | Expert in CE marking, EU MDR 2017, FDA submission & ISO 13485 Lead Auditor

Profile Summary

I have over 7 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable medical devices and CE Marking Certification (MDD 93/42/EEC and MDR 2017/745)& USFDA 510 (k) I have experience in routinely preparing a Clinical Evaluation Plan and Report (CER, according to MEDDEV 2.7/1-Rev.4), Biological Evaluation Plan and Report (BER, according to ISO 10993), Risk Management File (according to ISO 14971), Post-Market Surveillance Plan and Report (PMS), Post-Market Clinical Follow-up Plan and Report (PMCF, according to MEDDEV 2.12-2); Writing Stability Study Plan and Stability Study Report for Implantable Medical Device and Instruction for the Use of implantable Medical Devices classes IIb and III, according to Medical Device Regulations MDD 93/42/EEC and MDR 2017/745. I have the experience to register Medical device in US, European Countries and ASIAN Countries. I hold a Master's degree in Bio-Medical Engineering , from the DCRUST, State University In India.

Subject Matter Expertise

• ★ Product Compliance
• ★ Clinical Study Reports

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Market Research

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Stability/Shelf Life Testing, Product Evaluation, Product Validation, Prototyping

Work Experience

Manager - Regulatory and Quality Affairs

SIORA SURGICALS PVT. LTD.

2017 - Present

Manager Regulatory Affairs

AUXEIN MEDICAL

October 2013 - December 2016

Education

MASTER IN BIO-MEDICAL ENGINEERING

Deenbandhu Chhotu Ram University Of Science And Technology

July 2011 - July 2013

Certifications

• Certification details not provided.