Medical Device QMS Blog | ISO 13485, ISO 14971 & MDR Insights
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ISO 13485 from zero, episode ten: management re...
The final episode of ISO 13485 from zero: management review inputs and outputs, a six-point readiness check, preparing for the audit and keeping the system alive.
ISO 13485 from zero, episode ten: management re...
The final episode of ISO 13485 from zero: management review inputs and outputs, a six-point readiness check, preparing for the audit and keeping the system alive.
ISO 13485 from zero, episode nine: the internal...
Episode nine of ISO 13485 from zero: a risk-weighted audit program, auditor independence, product-based audit trails, well-written findings and follow-up.
ISO 13485 from zero, episode nine: the internal...
Episode nine of ISO 13485 from zero: a risk-weighted audit program, auditor independence, product-based audit trails, well-written findings and follow-up.
ISO 13485 from zero, episode eight: building a ...
Episode eight of ISO 13485 from zero: nonconforming product rules, CAPA inputs, triage, root cause investigation, safe actions and effectiveness checks.
ISO 13485 from zero, episode eight: building a ...
Episode eight of ISO 13485 from zero: nonconforming product rules, CAPA inputs, triage, root cause investigation, safe actions and effectiveness checks.
ISO 13485 from zero, episode seven: complaints,...
Episode seven of ISO 13485 from zero: feedback, the complaint process, reportability decisions, post-market surveillance and advisory notices or recalls.
ISO 13485 from zero, episode seven: complaints,...
Episode seven of ISO 13485 from zero: feedback, the complaint process, reportability decisions, post-market surveillance and advisory notices or recalls.
ISO 13485 from zero, episode six: production co...
Episode six of ISO 13485 from zero: production controls, cleanliness, device history records, traceability, IQ/OQ/PQ process validation and software used in production.
ISO 13485 from zero, episode six: production co...
Episode six of ISO 13485 from zero: production controls, cleanliness, device history records, traceability, IQ/OQ/PQ process validation and software used in production.
ISO 13485 from zero, episode five: purchasing a...
Episode five of ISO 13485 from zero: supplier evaluation criteria, three-level risk classification, quality agreements, purchasing information and incoming checks.
ISO 13485 from zero, episode five: purchasing a...
Episode five of ISO 13485 from zero: supplier evaluation criteria, three-level risk classification, quality agreements, purchasing information and incoming checks.
ISO 13485 from zero, episode four: design contr...
Episode four of ISO 13485 from zero: design planning, inputs, outputs, reviews, verification and validation, transfer and changes, and how they build the design history file.
ISO 13485 from zero, episode four: design contr...
Episode four of ISO 13485 from zero: design planning, inputs, outputs, reviews, verification and validation, transfer and changes, and how they build the design history file.
ISO 13485 from zero, episode three: risk manage...
Episode three of ISO 13485 from zero: separating business risk from product risk, building the ISO 14971 risk file, and feeding risk into every other process.
ISO 13485 from zero, episode three: risk manage...
Episode three of ISO 13485 from zero: separating business risk from product risk, building the ISO 14971 risk file, and feeding risk into every other process.
ISO 13485 from zero, episode two: the quality m...
Episode two of ISO 13485 from zero: the required quality manual, the medical device file, document control, records control and retention periods.
ISO 13485 from zero, episode two: the quality m...
Episode two of ISO 13485 from zero: the required quality manual, the medical device file, document control, records control and retention periods.
ISO 13485 from zero, episode one: your role, yo...
Episode one of ISO 13485 from zero: define your role in the supply chain, write a scope with justified exclusions, build a regulatory requirements register and record device classification.
ISO 13485 from zero, episode one: your role, yo...
Episode one of ISO 13485 from zero: define your role in the supply chain, write a scope with justified exclusions, build a regulatory requirements register and record device classification.
ISO 13485 Certification: Process, Timeline and ...
How medical device companies get ISO 13485:2016 certified: the steps, typical timelines, MDSAP and what drives the cost.
ISO 13485 Certification: Process, Timeline and ...
How medical device companies get ISO 13485:2016 certified: the steps, typical timelines, MDSAP and what drives the cost.
Quality leadership: designing the quality organ...
How a quality function should be organised at each stage of growth, the risk at each stage, reporting lines and what to measure.
Quality leadership: designing the quality organ...
How a quality function should be organised at each stage of growth, the risk at each stage, reporting lines and what to measure.
Templates for the work these guides describe
Editable Word and Excel tools for ISO 9001:2026 and ISO 13485. Instant download.