Celegence brings rich experience in providing end-to-end support on US FDA premarketing submission activities involving consultation for regulatory pathway and submission strategies, preparing technical documentation, and QSub meetings with FDA. This includes Medical Devices, Combination Products, Personal Protective Equipment, and devices containing software. Celegence also provides services such as US Agent, Official Correspondent and internal audits to ISO 13485 and 21 CFR 820.
Device listing and registration in FDA's FURLS database GUDID initial entry and maintenance.
Classification and submission planning
Premarket application preparation 510(k), PMA, or De Novo submissions.
Implementation of Quality System Regulation in compliance with 21 CFR 820
Pre-Market Approval document gap assessments/Authoring to demonstrate safety and efficacy.
Technical documentation
Non-Clinical studies (Bench, Animal, etc.)
Biocompatibility studies
Clinical Study
510(k) submissions utilizing Pre-Submission and Submission Issue meetings with FDA.
Developed and implemented domestic and International regulatory certification and clearance strategies
Submission documentation for De Novo, 510(k), PMA, Investigational Device Exemption, Emergency Use Authorization (EUA).
Summary Technical Documentation (STED)
Non-Clinical studies (Bench, Animal)
Clinical Study Reports
Reports for Sterilization, Biocompatibility studies,
Software verification and validation
EMC and human factors testing reports
Labelling documentation
Gap Analysis and Remediation of documentation for technical, PMS, QMS, and Harmonized standards
UDI/GTIN documentation
GUDID registrations and maintenance
Ophthalmology
Respiratory
Cosmetic
Surgery
Cardiovascular
Neurovascular
Female Reproductive Health
Gastroenterology
Renal Dialysis & Nephrology
Hematology
Diagnostic imaging
Orthopedics
Dental specialties
Oncology
Urology
Interventional radiology
General, electrosurgical & laparoscopic surgery
Our experts can provide consultation for submissions, liaise with regulatory agencies, lead projects for documentations, and implement QSR.
Team Lead - Medical Devices
Apoorva has 8 years' experience in the medical device industry and is Team Lead in the Medical Devices Team at Celegence. She manages documents for regulatory submissions and ensure compliance across multiple regions, including the EU, US, and Saudi FDA. She has authored and reviewed technical files, GSPRs, risk documents, QMS documents and various gap assessments for global regulations and standards. She also has extensive experience with ISO 14971 risk documentation and ISO 13485 quality management system. In addition to regulatory submissions, she supports regulatory intelligence projects, offering strategic insights into evolving medical device standards and regulations.
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25 Apr, 2025
25 Apr, 2025
25 Apr, 2025
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
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