From quality management systems and technical documentation to regulatory submissions, audits and post-market compliance, DnA provides hands-on support across the medical device lifecycle and global regulatory requirements.
Each service provides focused regulatory and quality support based on your device, market and compliance requirements.
QMS implementation, internal audits, management review and support for certification and surveillance audit readiness.
Technical documentation, GSPR, PMS, PMCF and regulatory support for medical devices entering or remaining in European markets.
Regulatory strategy and complete documentation support for Class II medical device 510(k) submissions.
Regulatory support for manufacturing, import, wholesale and test licences under India’s Medical Device Rules 2017.
Regulatory and quality support for manufacturers addressing MDSAP, Health Canada and Australian TGA requirements.
Human factors engineering, design validation and clinical study coordination to support medical device regulatory requirements.
Supplier qualification, vendor audits, CAPA follow-up and compliance support to strengthen quality across the supply chain.
Software lifecycle validation and cybersecurity compliance support aligned with applicable medical device and information security requirements.
Not sure which service fits? Start with what you’re trying to achieve, and we’ll help you identify the right regulatory support.
Support with EU MDR/IVDR documentation, GSPR, PMS, PMCF and Contract PRRC.
Hands-on help with ISO 13485 implementation, internal audits and certification preparation.
Help preparing the regulatory strategy and 510(k) documentation for Class II devices.
Guidance through CDSCO manufacturing, import, wholesale and test licence requirements.
Guidance for Health Canada, TGA, MDSAP and other international requirements.
Support with clinical studies, usability, human factors and design validation activities.
Support with IEC 62304, software validation, cybersecurity and information security requirements.
Support with supplier qualification, audits and CAPA follow-up to address compliance gaps.
Practical expertise that strengthens documentation, quality systems and ongoing medical device compliance.
Clinical evaluation support and evidence review aligned with medical device regulatory requirements.
Post-market surveillance and clinical follow-up support throughout the device lifecycle.
Structured internal audits to identify gaps and strengthen quality system readiness.
Support with corrective and preventive actions to address findings and improve compliance.
Human factors, usability and validation support for medical device development activities.
Practical training that helps internal teams understand regulatory and quality requirements.
It depends on your device, target market and current stage. DnA can review your requirements and help identify the relevant regulatory support.
Yes. DnA works across EU MDR, US FDA, CDSCO, Health Canada, TGA and MDSAP requirements.
Yes. Support can continue through quality systems, audits, PMS, PMCF and other ongoing compliance activities.