Shanghai SUNGO Lab
Hefei SUNGO Lab
Medical Device Testing Knowledge Base
Two labs, two numbers, and nobody at fault. How to check traceability, where uncertainty comes from, how decision rules change conclusions.
Retention is not shelving leftovers. Which items need retained units, what condition to keep, how to store them, whether a retest can hold up.
Reports from one lab, some marked, some not. The four elements that lock a scope, how to check the annex yourself, what the mark proves.
A disappointing result is not grounds for a retest. Where retesting, repeat testing and arbitration differ, what to file, and who pays.
Most testing delays happen before the bench: scope, sample status, plan rounds, missing documents. Node-by-node fixes and a pre-shipment checklist.
Across parallel market submissions you can reuse samples and raw data, but never the report conclusions. How to scope, sample and schedule.
Linking risk files to test reports comes down to one traceability table: the columns it needs, three ways it fails to line up, and what auditors ask.
Test conclusions cover only the version submitted. How to define version identifiers, which changes force a re-run, and what the package must hold.
Accompanying documents get verified clause by clause, not filed as attachments. Five checks to run before samples ship, plus what each error costs.
Extraction media, ratio, conditions and sample state decide whether a report supports your device. How to choose, and five ways reports get voided.
A risk-driven route for biological evaluation: device description, then chemical characterization, and animal testing only where risk will not close.
Why electrical safety items fail, which problems are design-stage and which can still be fixed on a prototype, plus a pre-submission self-check.
How to classify an EMC failure down to port and coupling path, pick fixes in cost order, and scope the retest to the affected items.
Whose conclusion feeds whose, when samples can be shared, when seal parameters must be locked: three handoff points, four rework traps.
When accelerated data can stand alone, when the real-time group must be committed, and how the two aging tracks cross-reference.
Applied standards versus acceptance criteria, model coverage and sample condition: how to fill in a test request form without forcing a reissue.
Where type testing and registration testing diverge on standards, samples and coverage, plus seven cases where a type report cannot be reused.
How to grade a material, supplier, sterilization or packaging change, decide what needs retesting, and what only needs a documented rationale.
A coverage rationale needs an exhaustive difference matrix, not a sense of similarity: three preconditions, picking representatives, and the hard limits.
Report rejections happen at three points, and most triggers are locked in on the request form. Field-by-field self-check, plus what accreditation proves.
Plan test samples by where each unit ends up, not by counting ordered line items: three disposition types, sequencing rules, a pre-shipment checklist.
GB 8368 covers gravity-feed infusion sets only. Sort the device type first, then map product, method and biological evaluation standards.
Three questions - single-use or reprocessable, sterile or not, and how the device contacts the body - settle most of the test list.
EMC emission reports sit under YY 9706.102 or IEC 60601-1-2; GB 4824 and CISPR 11 supply limits. How to layer them and group your device.
How the chemical analysis and biological test parts of GB/T 14233 fit together: who sets each item, extraction rules, and what to submit.
Whether a product follows YY/T 0148 or the dressing route, why peel force fails to reproduce between labs, and what to prepare before testing.
How to prepare usability engineering evidence for IEC 62366: which route fits your device, which documents to assemble, and when to involve the lab.
Dental products span many categories: check standard applicability by product form first, then build the test list and prepare samples.
Work out which reprocessing claims need validation, how to justify the worst-case device configuration, and what to prepare before testing.
How to decide whether systemic toxicity applies, which tier to run, and why material-mediated pyrogens and endotoxin are not interchangeable.
How to scope a YY 0285 test list by failure mode, and what sample state, grouping and paperwork keep a catheter submission moving.
A practical guide to deciding whether a device is ME equipment, which shock protection class applies, and where the applied parts are.
Scope questions, syringe-specific failure paths, sample state and the documents to settle before GB 15810 testing of sterile single-use syringes.
How to decide whether genotoxicity testing applies, which endpoints to cover, how to prepare the test article, and what to do with a positive.
How auditors trace a test report back to design inputs, sample representativeness and outsourced laboratory evaluation, and what to fix first.
How to turn risk control measures into test items, which risks need other forms of evidence, and what to prepare before submitting samples.
Bioburden for sterilization validation or for release? Getting sampling units, recovery efficiency and bacteriostasis screening right the first time.
Half-cycle or bioburden approach, loading patterns, process challenge devices and product families for an ISO 11135 / GB 18279 EO validation.
How to fix your EN 13726 test list before shipping samples, and why the EN and YY/T 0471 routes can share samples but not reports.
You have GB or EN 455 glove reports and a US buyer. This sets out which route your gloves take, what to test, and how to prepare samples.
Air compression therapy devices split across two FDA product codes, JOW and IRP. Which one you file under decides your test list, predicate and route.
Not sure a third-party test report will hold up in your target market? How to tell what CMA, CNAS and IAS each prove, and when to retest.
Chinese national standard glove reports rarely transfer to the EU. Which of the four EN 455 parts you can reuse, and which you have to run again.
How radiation doses are established and kept valid: choosing between VDmax and Method 1, the role of bioburden, and the GB 18280.1 transition.
How to scope an ISO 10993-18 extractables and leachables study, what changed in ISO 10993-17, and what gets you a deficiency letter.