Deepa D
Deepa Johnny
Global RA/QA Consultant specializing in regulatory affairs and quality assurance consulting for medical device manufacturers. Certified Lead Auditor (ISO 13485:2016) with nearly a decade of experience supporting medical device manufacturers in achieving ISO 13485, EU MDR/IVDR, US FDA, and CDSCO compliance.
Omani-born Canadian mezzo-soprano Deepa Johnny has emerged as one of the most captivating young voices on the international opera stage. She has garnered widespread critical acclaim for her powerful portrayals, including Carmen at Opéra de Rouen Normandie and Penelope in Il ritorno d’Ulissein Patria at Festival d’Aix-en-Provence. Deepa gained recognition in major competitions while studying at Indiana University, winning the Andre Bourbeau Best Canadian Artist award and the ICI Musique People’s Choice award at the 2022 Concours Musical International de Montreal. She also won the Western Canada District of the 2020 Metropolitan Opera National Council Auditions and joined LA Opera’s Domingo-Colburn Stein’s Young Artist Program, debuting in the world-premiere of Omar. Deepa has also debuted at Opéra de Paris as Kasturbai in Phillip Glass' Satyagraha.
About
**Who they are**
Deepa D is a Global RA/QA Consultant specializing in regulatory affairs and quality assurance consulting for medical device manufacturers.
**Expertise & scope**
- Specializes in regulatory affairs and quality assurance consulting for medical device manufacturers.
- Expertise includes ISO 13485, EU MDR/IVDR, US FDA 21 CFR 820, CDSCO, MDSAP, Health Canada, and TGA compliance.
- Offers services such as QMS implementation, technical documentation, risk management, regulatory submissions, and supplier qualification.
- Experienced in leading audits, managing regulatory remediation, and securing approvals across multiple jurisdictions.
**Reputation / proof points**
- Certified Lead Auditor (ISO 13485:2016).
- Nearly a decade of experience supporting medical device manufacturers.
Deepa D is a Global RA/QA Consultant specializing in regulatory affairs and quality assurance consulting for medical device manufacturers.
**Expertise & scope**
- Specializes in regulatory affairs and quality assurance consulting for medical device manufacturers.
- Expertise includes ISO 13485, EU MDR/IVDR, US FDA 21 CFR 820, CDSCO, MDSAP, Health Canada, and TGA compliance.
- Offers services such as QMS implementation, technical documentation, risk management, regulatory submissions, and supplier qualification.
- Experienced in leading audits, managing regulatory remediation, and securing approvals across multiple jurisdictions.
**Reputation / proof points**
- Certified Lead Auditor (ISO 13485:2016).
- Nearly a decade of experience supporting medical device manufacturers.
Additional information
This provider offers comprehensive regulatory and quality assurance support tailored for medical device manufacturers navigating complex global compliance landscapes. Their services are designed to assist clients in achieving and maintaining adherence to critical international standards and regulations, including ISO 13485, EU MDR/IVDR, and FDA requirements. They focus on practical implementation, from QMS development and risk management alignment to managing submissions and audits. Buyers can expect a structured approach to compliance, ensuring documentation is robust and regulatory pathways are clearly defined.
Key Highlights
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Global RA/QA Consultant helping medical device manufacturers achieve ISO 13485, EU MDR, FDA, and CDSCO compliance.
Source
“Global RA/QA Consultant helping medical device manufacturers achieve ISO 13485, EU MDR, FDA, and CDSCO compliance”
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Specialized in ISO 13485 quality management systems, ISO 14971 risk management, and regulatory remediation initiatives across international markets.
Source
“Specialized in ISO 13485 quality management systems, ISO 14971 risk management, and regulatory remediation initiatives across international markets”
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Certified Lead Auditor (ISO 13485:2016).
Source
“CERTIFIED LEAD AUDITOR (ISO 13485:2016)”
Certifications & Trust Signals
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Nearly a decade of experience supporting medical device manufacturers in achieving and maintaining global regulatory compliance.
Source
“nearly a decade of experience supporting medical device manufacturers in achieving and maintaining global regulatory compliance”
Buyer Snapshot
Best for
- Medical device manufacturers seeking global regulatory compliance.
- Companies needing support with ISO 13485, EU MDR/IVDR, and FDA regulations.
How engagement typically works
- Consultative approach to regulatory and quality assurance.
- Focus on practical implementation and documentation.
Typical deliverables
- QMS implementation and audits.
- Technical documentation and regulatory submissions.
- Risk management strategies and remediation.
- Compliance support for various international markets.
Good to know
- Best when requiring specialized expertise in medical device regulatory affairs and quality assurance.
HQ:
Canada
Languages:
English
Status:
claimed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Named PRRC:
No
eudamed_reg_support
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices, Certificates, Vigilance
Supports Training Enablement:
Yes
Data Load Support Level:
Done-for-you
Turnaround SLA:
3-7 days
Additional prrc_service Details
Device Classes Supported
Class II
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
Regulatory Affairs and Quality Assurance consultant with nearly a decade of experience. Certified Lead Auditor (ISO 13485:2016). Expertise in ISO 13485, ISO 14971, EU MDR/IVDR, US FDA 21 CFR 820, CDSCO, MDSAP, Health Canada, and TGA.
Regulatory Experience
Nearly a decade of experience in regulatory affairs and quality assurance for medical device manufacturers, covering international markets.
Onboarding Steps
Insufficient unique content to generate description
