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EN ISO 13485:2016 · Medical devicesQuality management for design, production, installation and servicing of medical devices — opening regulated markets worldwide.
Quality management for design, production, installation and servicing of medical devices — harmonised with ISO 9001 and GMP, opening regulated markets worldwide.
Scope, sites and audit duration defined; quotation issued.
1–3 daysDocumentation review and readiness assessment.
Remote / on-siteOn-site assessment of implementation and effectiveness.
On-siteIndependent decision; entry in the public register.
Valid 3 yearsAnnual audits; re-certification in year three.
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ReadOur specialists will answer your questions, run a diagnostic audit if needed and help you fill in the application.
