Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 300 /hr

★★★★★

☆☆☆☆☆

Hire Regulatory 1.

India

USD 300 /hr

Medical Device and IVD Regulatory Expert

Profile Summary

* Expert knowledge on Medical Device, In-vitro Directive and Medical Device regulation in India * Qualified ISO Lead auditor, accomplished more than 60 audits which includes QMS- ISO 13485 certification audit, Internal audit, CRO audit, third party manufacturer audit and supplier audit * Expertise in documentation and certification for CE marking, 510(K) for USFDA and CDSCO submission • Medical device clinical trial – by providing guidance in protocol writing, clinical trial report and part of the technical team in completing the trial audit, clinical trial conduct. • Provided training for Quality System and Regulatory training – (In-house and external) • Design control, CAPA, Complaint Handling, * Documentation for 510(K) premarket notifications (USFDA), Technical Files for CE marking, • Handling team for ISO 13485 documentation, implementation and certification • Supported for Notified Body assessment response • Sterilization validation and Validation studies for regulatory submission • CDSCO – Import/ export, Test License and Manufacturing License for all class of MD • Achievements- Manufacturing license in a week’s time, ISO 13485 certification

Subject Matter Expertise

• ★ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Product Compliance

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Gap Analysis

Consulting Scientific and Technical Consulting, Regulatory Consulting

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

Work Experience

Founder

regulatory1

January 2015 - Present

Education

Masters of Science

Kuvempu University

January 1998 - January 2000

Certifications

• ISO 13485 lead auditor

  UL LLC

  January 2021 - January 2021