Supporting medical device organisations with practical QMS implementation, internal audits, management reviews, and preparation for certification and surveillance audits.
Whether you are building a medical device QMS from the ground up or improving an existing system, DnA provides practical ISO 13485 support that fits the way your organisation actually works. The focus is on clear processes, effective implementation and evidence that stands up to audit scrutiny.
Implementing ISO 13485:2016 QMS for the first time
Preparing for certification or surveillance audits
Addressing recurring audit findings, CAPA or document control gaps
Strengthening supplier controls, internal audits and management reviews
Build an ISO 13485-aligned quality system with clear processes, responsibilities, controlled documentation and records.
Assess QMS Implementation & Remediation through structured internal audits, identify gaps and support corrective actions before external audits.
Prepare processes, records and teams for certification or surveillance audits through focused readiness reviews and gap closure.
DnA Regulatory Solutions helps medical device organisations build ISO 13485 quality systems around their actual processes, responsibilities and regulatory needs. The focus goes beyond documentation, helping teams put the QMS into practice and maintain reliable quality records.
Clear SOPs, work instructions, templates and controlled records
Defined process ownership, responsibilities and staff training
CAPA, supplier controls and management review processes that support continual improvement
Built for Everyday Use:
A strong QMS should work beyond audit day. DnA helps teams understand their responsibilities, maintain objective evidence and keep quality processes working as the organisation grows.
This direction is well supported by the blueprint, which specifically says DnA develops a proportionate QMS based on actual workflows, including controlled SOPs, work instructions, templates, roles, competence, CAPA, supplier controls, management review and implementation training.
DnA supports QMS development and implementation, including SOPs, work instructions, document control, CAPA, supplier controls, management reviews, internal audits and staff training.
Yes. DnA can review QMS readiness, conduct internal audits, identify gaps and help teams prepare the records and evidence required for certification or surveillance audits.
Yes. Existing systems can be reviewed for recurring findings, documentation gaps, ineffective CAPA or other areas that may need improvement.
Build a QMS that works in day-to-day operations and stays ready for certification, surveillance and ongoing quality requirements.