From quality systems to market compliance
DnA Regulatory Solutions is a medical device Regulatory Affairs and Quality Assurance consultancy led by Deepa Ajithkumar, a Principal Regulatory Affairs & Quality Assurance Consultant with A Decade of Medical Device Regulatory & Quality Excellence. DnA works with manufacturers across global markets, providing hands-on support for quality management systems, technical documentation, regulatory submissions, audits and ongoing compliance. With experience spanning EU MDR, ISO 13485, US FDA, CDSCO and other international requirements, DnA brings practical regulatory knowledge to every engagement. The focus is simple: understand the device, identify the applicable requirements, and help teams build the documentation and quality processes needed to move forward with confidence.
To provide practical regulatory and quality support that helps medical device manufacturers meet compliance requirements and access global markets.
To be a trusted regulatory and quality partner for medical device manufacturers navigating evolving requirements across global markets.
Integrity, quality and practical thinking guide our approach, with every engagement focused on clear, reliable and responsible regulatory support.
To work closely with clients, understand their regulatory needs and provide hands-on support throughout the medical device lifecycle.
Supporting medical device manufacturers across regulatory, quality and compliance requirements.
Regulatory strategy, submissions and licensing support across key global markets.
Technical files, GSPR, clinical evaluation, PMS and PMCF documentation support.
ISO 13485 implementation, internal audits, supplier audits and certification readiness.
Support across EU MDR, US FDA, CDSCO, Health Canada, TGA and MDSAP requirements.
Nearly 10 years of hands-on medical device industry experience.
DnA combines regulatory and quality expertise with hands-on support, helping medical device manufacturers address compliance requirements throughout the product lifecycle.
Practical guidance aligned with device requirements and target regulatory markets.
From quality systems and documentation to submissions and post-market compliance.
Supporting risk management, CAPA and audit readiness through practical regulatory guidance.
ISO 13485 implementation, internal audits and ongoing quality system support.
Medical Device Industry Experience
ISO 13485 Certification Achieved
EU MDR Technical Files Prepared
CDSCO Licences Obtained
Successful US FDA Submission
Reduction in Audit Findings
A clear, structured process that keeps regulatory and quality requirements organised from assessment through ongoing support.
We understand the device, target market and applicable regulatory requirements.
We review documentation, quality systems and existing compliance gaps.
We establish priorities, regulatory requirements and the documentation needed.
We assist with documentation, submissions, audits and quality activities.
We support post-market activities and ongoing regulatory compliance requirements.
Discuss your medical device requirements with DnA and identify the regulatory and quality support needed for the next stage.