How Can Medical Device Companies Prepare Their Documentation and…
For many Class II medical devices seeking entry into the United States, the 510(k) pathway is an…
End-to-end regulatory affairs and quality assurance consulting for medical device manufacturers across EU MDR/IVDR, US FDA, ISO 13485, CDSCO and global market access.
DnA Regulatory Solutions is led by Deepa Ajithkumar, a Global Regulatory Affairs & Quality Consultant with a decade of medical device regulatory & quality excellence.
From quality management systems and technical documentation to regulatory submissions and audits, DnA supports medical device manufacturers in meeting regulatory requirements across global markets.
Hands-on consulting support for medical device compliance, quality systems and regulatory documentation.
Supporting regulatory and quality requirements across a broad range of medical device technologies and product categories.
Trusted by medical device companies and organisations across global markets for regulatory and quality consulting support.
From quality systems and technical documentation to global submissions, audits and post-market compliance.
Technical documentation, GSPR, PMS and PMCF support for European regulatory compliance.
Regulatory strategy and documentation support for Class II medical device submissions.
QMS implementation, internal audits, certification support and surveillance audit readiness.
Support for manufacturing, import, wholesale and test licences under Medical Device Rules 2017.
Human factors engineering, design validation and clinical study support for medical devices.
Regulatory support for MDSAP, Health Canada and TGA market requirements.
Supplier qualification, vendor audits and compliance reviews to strengthen quality management.
Practical outcomes across quality systems, technical documentation, regulatory licensing, submissions and audits.
QMS documentation, internal audits and management review completed within a three-month certification support engagement.
Technical documentation support delivered across medical devices covering different classifications and regulatory requirements.
Regulatory support provided across manufacturing, import, test and other applicable CDSCO licensing requirements.
Submission documentation and regulatory support provided for a Class II medical device 510(k) pathway.
Supplier audit and CAPA support focused on addressing findings, corrective actions and stronger compliance readiness.
Power BI regulatory dashboards developed to support structured, real-time compliance monitoring.
From quality systems to post-market compliance, with support across the device lifecycle.
Hands-on regulatory and quality expertise across medical devices and global markets.
Experience across EU MDR, US FDA, CDSCO, Health Canada, TGA and MDSAP.
Successful certifications, technical files, licences and submissions across multiple medical device classes.
Practical support for internal audits, supplier qualification, CAPA and compliance improvement.
Helping teams understand regulatory requirements and manage compliance with greater confidence.
DnA supports medical device manufacturers with regulatory submissions, licensing and compliance requirements across established international regulatory pathways.
Regulatory support for market entry, submissions, licensing and ongoing medical device compliance.
EU MDR & IVDR Compliance
US FDA 510(k) Submissions
CDSCO Regulatory Licensing
Health Canada Regulatory Support
TGA & MDSAP Compliance Support
Real experiences from teams supported through regulatory, quality and compliance requirements.
Tell us about your medical device, current regulatory stage and the support you need. DnA can help identify the right approach for your compliance requirements.
Tell us about your device and regulatory needs.
For many Class II medical devices seeking entry into the United States, the 510(k) pathway is an…
Accessing the European medical device market involves more than preparing a single regulatory document. Under the EU…
Medical device quality is not something that can be managed only when an audit is approaching. It…