Independent evaluation per ISO 13485:2016.
Quality management system for medical devices: design, production, storage and distribution with regulatory traceability.
Current state vs ISO 13485 requirements.
Clause-by-clause against ISO 13485:2016.
Prioritized findings for senior management.
Roadmap with milestones, owners and deadlines.
Document review and interviews within 72 hours.
Gap analysis against ISO 13485:2016.
Prioritized findings and action plan.
We verify controls operate with objective evidence.
We transfer audit criteria to your team.
Ready to act on these findings?
Any organization whose operational scope aligns with ISO 13485:2016. An independent assessment determines readiness level.
Fernando Arrieta offers evaluation, assessment, and methodological guidance services for management systems. These activities are independent of the certification process, which is carried out exclusively by accredited certification bodies.