Deepa Ganesh
Deepa Ganesh is a Senior Regulatory Affairs Consultant at Certification Experts, bringing over 15 years of global experience in medical device compliance, clinical documentation, and quality management systems.
Her expertise covers the full regulatory spectrum, from EU MDR and IVDR compliance to clinical evaluation, technical documentation review, and regulatory strategy development. Deepa has extensive experience compiling, reviewing, and submitting technical files for a wide range of medical device categories, ensuring that each submission meets the latest European and international requirements.
She specialises in:
- Clinical and Performance Evaluations (CEP, CER, PEP,PER, literature reviews)
- Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF)
- Risk and Performance Analyses
- QMS Audits under ISO 13485, ISO 9001, GDPMD, and GDPMDS
Deepa has worked closely with Notified Bodies, competent authorities, and certification bodies, managing nonconformities and CAPAs with precision and efficiency. Her pragmatic, detail-oriented approach helps manufacturers achieve and maintain compliance with confidence.
LinkedIn: Deepa Ganesh | LinkedIn
Accreditations:
- Clinical Investigation for Medical Devices & ISO 14155
- Principles and Practice of Clinical Research
- Lead Auditor ISO 13485:2016
- Operations Management
- Pharmacy