Medical Device QMS Blog | ISO 13485, ISO 14971 & MDR Insights
Latest articles
Quality leadership: running ISO 9001 and ISO 13...
Build one common core for both standards, write each process to the stricter requirement, and run one audit programme and one management review.
Quality leadership: running ISO 9001 and ISO 13...
Build one common core for both standards, write each process to the stricter requirement, and run one audit programme and one management review.
Quality leadership: building a cost of quality ...
The four cost of quality categories, where the data lives, working with finance from the start and using the model to decide.
Quality leadership: building a cost of quality ...
The four cost of quality categories, where the data lives, working with finance from the start and using the model to decide.
Quality leadership: writing a quality strategy ...
A policy says what a company values; a strategy says what it will do, spend and stop doing. How to write one on two pages.
Quality leadership: writing a quality strategy ...
A policy says what a company values; a strategy says what it will do, spend and stop doing. How to write one on two pages.
ISO 13485 from zero, episode ten: management re...
Episode ten of ten: management review inputs and outputs, a six-point readiness check, choosing a certification body and keeping the system alive.
ISO 13485 from zero, episode ten: management re...
Episode ten of ten: management review inputs and outputs, a six-point readiness check, choosing a certification body and keeping the system alive.
ISO 13485 from zero, episode nine: the internal...
Episode nine of ten: a risk-weighted audit programme, auditor independence, product audit trails, writing findings and following up to closure.
ISO 13485 from zero, episode nine: the internal...
Episode nine of ten: a risk-weighted audit programme, auditor independence, product audit trails, writing findings and following up to closure.
ISO 13485 from zero, episode eight: building a ...
Episode eight of ten: nonconforming product and concessions, CAPA inputs, triage, root cause, actions that create no new risk, and effectiveness checks.
ISO 13485 from zero, episode eight: building a ...
Episode eight of ten: nonconforming product and concessions, CAPA inputs, triage, root cause, actions that create no new risk, and effectiveness checks.
ISO 13485 from zero, episode seven: complaints,...
Episode seven of ten: feedback, the complaint process, reportability decisions, post-market surveillance, advisory notices and recalls.
ISO 13485 from zero, episode seven: complaints,...
Episode seven of ten: feedback, the complaint process, reportability decisions, post-market surveillance, advisory notices and recalls.
ISO 13485 from zero, episode six: production co...
Episode six of ten: controlled production, cleanliness, the device history record, traceability, IQ, OQ and PQ, and software used in production.
ISO 13485 from zero, episode six: production co...
Episode six of ten: controlled production, cleanliness, the device history record, traceability, IQ, OQ and PQ, and software used in production.
ISO 13485 from zero, episode five: purchasing a...
Episode five of ten: supplier evaluation criteria, risk classification, quality agreements, purchasing information, incoming checks and re-evaluation.
ISO 13485 from zero, episode five: purchasing a...
Episode five of ten: supplier evaluation criteria, risk classification, quality agreements, purchasing information, incoming checks and re-evaluation.
ISO 13485 from zero, episode four: design contr...
Episode four of ten: design planning, inputs, outputs, reviews, verification and validation, transfer, changes and the design history file.
ISO 13485 from zero, episode four: design contr...
Episode four of ten: design planning, inputs, outputs, reviews, verification and validation, transfer, changes and the design history file.
ISO 13485 from zero, episode three: risk manage...
Episode three of ten: business risk versus product risk, the risk management plan, hazards to harms, controls, and putting risk into every other process.
ISO 13485 from zero, episode three: risk manage...
Episode three of ten: business risk versus product risk, the risk management plan, hazards to harms, controls, and putting risk into every other process.
ISO 13485 from zero, episode two: the quality m...
Episode two of ten: the 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 ten: the quality manual, the medical device file, document control, records control and retention periods.
Templates for the work these guides describe
Editable Word and Excel tools for ISO 9001:2026 and ISO 13485. Instant download.