https://www.gladiolusqrs.com/blog daily 0.75 2026-07-28 https://www.gladiolusqrs.com/blog/significant-or-not-the-health-canada-decision-that-holds-up-your-change monthly 0.5 2026-07-28 https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/1785257441085-06CRO70IXY8WT7PHN1OS/GettyImages-1447288372.jpg Blog - Significant or Not? The Health Canada Decision That Holds Up Your Change - The purpose is narrow. It helps manufacturers determine whether a proposed change to a Class III or IV medical device licence is significant, which in turn determines whether an amended licence application must be submitted before the change is implemented. The regulatory hook is section 34 of the Medical Devices Regulations, which describes the changes that require a licence amendment application, including a significant change proposed to a licensed Class III or IV device under subsection 34(a). The guidance sets out the types of changes captured by the regulatory definition and pairs them with worked examples, so that manufacturers interpret the same regulation the same way. Health Canada is explicit that the examples illustrate rather than exhaust the possibilities. It is not feasible to describe every change a device might undergo, so judgement still applies. https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/65143643-ff79-401d-b9f1-3d793f6f5b7c/Realistic+high-resolution+corporate+photograph+of+a+professional+standing+at+a+desk+reviewing+documents%2C+pausing+mid-decision%2C+with+a+high-tech+realistic+modern+day+medical+device+component+like+a+glucometer+or+oxygen+measuring+device+on+th.jpg Blog - Significant or Not? The Health Canada Decision That Holds Up Your Change - The practical work sits upstream of the decision. A significant change determination is only as good as the change impact assessment behind it, and that assessment depends on knowing what the change actually touches: the design, the risk file, the manufacturing process, the labelling, and any higher-class device the product is used with. Teams that handle this well have a change control procedure that routes every proposed change through an explicit significance assessment, records the reasoning, and links it to the supporting evidence. Teams that struggle tend to make the call informally and document it later, which works until someone asks why a particular change was not considered significant. https://www.gladiolusqrs.com/blog/regulatory-roundup-canadas-mdel-overhaul-the-eu-rep-symbol-and-a-uk-signal-jy77t monthly 0.5 2026-07-14 https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/e73522b7-9383-4d01-8ae6-07b6685ad7f2/2.png Blog - Post-Market Surveillance That Holds Up: What MDCG 2025-10 Expects - In December 2025, the Medical Device Coordination Group published MDCG 2025-10, a comprehensive EU guidance document on post-market surveillance covering both medical devices and IVDs. It doesn't create new legal obligations. What it does is spell out, in practical detail, what competent authorities and notified bodies expect a working PMS system to look like under the MDR and IVDR. That makes it the reference point your next audit will measure against, which is reason enough to read your own PMS system against it now. https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/1ec639b7-041c-44cd-9b9e-61cf0a2fc9ca/Untitled+design+%281%29.png Blog - Post-Market Surveillance That Holds Up: What MDCG 2025-10 Expects - The practical exercise is to take your current PMS plan and check it against what MDCG 2025-10 lays out. Does it name proactive data sources, or does it lean almost entirely on complaints? Are there real indicators and thresholds, or just a description of monitoring? Can you show, with documented examples, PMS data actually updating your risk management file, your clinical evaluation, or your labelling? If those links are implied rather than evidenced, the plan may read well, but it will not hold up when someone tests whether the system is actually working. This is interpretation rather than a new requirement: MDCG 2025-10 doesn't oblige you to rewrite a compliant PMS plan. But a plan read cold against the guidance, before a notified body reads it, tends to reach the audit in far better shape. https://www.gladiolusqrs.com/blog/mdsap-certification-explained-one-audit-for-five-medical-device-markets monthly 0.5 2026-07-06 https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/324c6cf2-2de6-4477-858c-3a8380a9a177/professional+photo+of+Realistic+high-resolution+corporate+photograph+of+a+professional+at+a+desk+reviewing+quality+management+documents+alongside+a+computer+screen+showing+charts+and+data%2C+modern+office+setting%2C+focused+and+calm+mood%2C+w+%281%29.jpg Blog - MDSAP Certification Explained: One Audit for Five Medical Device Markets - For a medical device manufacturer selling into more than one country, audits used to mean repetition. A separate inspection for each regulator, each on its own schedule, each pulling your quality team off their work for another week. The Medical Device Single Audit Program (MDSAP) was built to collapse that into one. The idea is simple. A single audit, conducted by a recognised third-party auditing organisation, can satisfy the quality management system requirements of five regulators at once: Australia, Brazil, Canada, Japan, and the United States. The execution is where medical device manufacturers underestimate what's involved. This post explains how MDSAP certification works, where it's mandatory rather than optional, and what tends to catch teams off guard when the audit actually arrives. https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/a7bdce2d-e323-4882-b986-e207521485fd/professional+photo+of+Realistic+high-resolution+corporate+photograph+of+a+professional+audit+scene_+two+people+at+a+modern+conference+table+reviewing+quality+documents+and+a+laptop+together%2C+one+holding+a+printed+checklist%2C+with+a+world+glo.jpg Blog - MDSAP Certification Explained: One Audit for Five Medical Device Markets - Preparing The Right Way The most useful preparation reads your QMS the way an auditor will, ahead of time, against the MDSAP task model and the country-specific requirements for the markets you actually include. That means confirming procedures are implemented and retrievable, that prior corrective actions hold up as effective, and that the regulatory overlay for each in-scope country is covered rather than assumed. https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/98c4d7ac-16c4-4ffd-86a6-935e68dae44c/Before+The+Audit+%281%29.png Blog - MDSAP Certification Explained: One Audit for Five Medical Device Markets - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://www.gladiolusqrs.com/blog/regulatory-roundup-canadas-mdel-overhaul-the-eu-rep-symbol-and-a-uk-signal monthly 0.5 2026-07-11 https://www.gladiolusqrs.com/blog/fdas-unique-device-identification-udi-system-and-gudid-registration-compliance-and-best-practices monthly 0.5 2025-02-27 https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/3594b1a9-3695-491d-a720-ea39a619fbbc/Medical+Device+%281%29.jpg Blog - FDA’s Unique Device Identification (UDI) System and GUDID Registration: Compliance and Best Practices - UDI Example* UDI Example* https://www.gladiolusqrs.com/blog/ema-launches-early-scientific-advice-program-for-high-risk-medical-devices monthly 0.5 2025-02-24 https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/1739860735528-N3FSGA7L39TC9E4NU00J/GettyImages-1031313036.jpg Blog - EMA Launches Early Scientific Advice Program for High-Risk Medical Devices LEARN MORE ABOUT OUR EU REGULATORY SERVICES HERE https://www.gladiolusqrs.com/blog/qmsr-harmonizing-us-fda-qsr-with-iso-134852016-key-insights-for-manufacturers monthly 0.5 2025-02-18 https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/7971520d-939d-421c-9e3d-e48c648b561a/Screenshot+2025-02-06+at+6.13.46%E2%80%AFPM+%282%29.png Blog - QMSR: Harmonizing US FDA QSR with ISO 13485:2016 – Key Insights for Manufacturers - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://www.gladiolusqrs.com/blog/fda-510k-process-in-2025-what-manufacturers-need-to-know-l7lxy monthly 0.5 2025-02-05 https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/1738735202603-GT1V6X4BZXU1RH29X4A5/GettyImages-1397665291.jpg Blog - FDA 510(k) Process in 2025: What Manufacturers Need to Know - Preparing for the FDA 510(k) in 2025: Steps for Manufacturers https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/1738735217711-ZABPUQ1NXIQXPGLP3MDV/GettyImages-1395461893.jpg Blog - FDA 510(k) Process in 2025: What Manufacturers Need to Know - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://www.gladiolusqrs.com/blog/critical-role-of-risk-management monthly 0.5 2025-11-13 https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/1721273966505-K5NXO3C4V2WJV558U20B/GettyImages-1364371014.jpg Blog - The Critical Role of Risk Management in Medical Device Development - Make it stand out Whatever it is, the way you tell your story online can make all the difference. https://images.squarespace-cdn.com/content/v1/65386b252aff0840c363691b/1721273723960-QQ8GN1EJ51DE43PZ7I7C/GettyImages-1395454069.jpg Blog - The Critical Role of Risk Management in Medical Device Development - 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