Testing & Standards Matrix
Define your device profile below to see which ISO/IEC standards and tests apply. Applicability, estimated costs, and relevant parts are calculated automatically.
Device Profile
Required Standards
4
Estimated Total Cost
$47K – $195K
Total Standards
12
| Standard | Name | Applicability | Markets | Est. Cost | Details |
|---|---|---|---|---|---|
ISO 13485 | Quality Management Systems | Required | US (FDA)EU (MDR)Singapore (HSA)+11 | $20K – $60K | |
ISO 13485 RequiredQuality Management SystemsSpecifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. $20K – $60K 14 markets US (FDA)EU (MDR)Singapore (HSA)Australia (TGA)CanadaJapan (PMDA)South Korea (MFDS)China (NMPA)India (CDSCO)Malaysia (MDA)Thailand (Thai FDA)Vietnam (MOH)Philippines (FDA)Hong Kong (MDCO) | |||||
ISO 14971 | Risk Management | Required | US (FDA)EU (MDR)Singapore (HSA)+11 | $10K – $30K | |
ISO 14971 RequiredRisk ManagementSpecifies terminology, principles, and a process for risk management of medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical devices. $10K – $30K 14 markets US (FDA)EU (MDR)Singapore (HSA)Australia (TGA)CanadaJapan (PMDA)South Korea (MFDS)China (NMPA)India (CDSCO)Malaysia (MDA)Thailand (Thai FDA)Vietnam (MOH)Philippines (FDA)Hong Kong (MDCO) | |||||
ISO 10993 | Biocompatibility | Required | US (FDA)EU (MDR)Canada+5 | $15K – $100K | |
ISO 10993 RequiredBiocompatibilityEvaluates the biological effects of medical devices on the body. Covers a range of tests from cytotoxicity to systemic toxicity depending on the nature and duration of body contact. $15K – $100K 8 markets US (FDA)EU (MDR)CanadaAustralia (TGA)Japan (PMDA)China (NMPA)South Korea (MFDS)Singapore (HSA) | |||||
ISO 15223-1 | Medical Device Symbols for Labelling | Required | US (FDA)EU (MDR)Singapore (HSA)+11 | $2K – $5K | |
ISO 15223-1 RequiredMedical Device Symbols for LabellingIdentifies symbols used to convey information on medical device labels and packaging. Covers symbols for safe use, storage conditions, date of manufacture, expiry, lot numbers, and more. $2K – $5K 14 markets US (FDA)EU (MDR)Singapore (HSA)Australia (TGA)CanadaJapan (PMDA)South Korea (MFDS)China (NMPA)India (CDSCO)Malaysia (MDA)Thailand (Thai FDA)Vietnam (MOH)Philippines (FDA)Hong Kong (MDCO) | |||||
IEC 62366-1 | Usability Engineering | Recommended | US (FDA)EU (MDR)Canada+3 | $5K – $20K | |
IEC 62366-1 RecommendedUsability EngineeringSpecifies a process for a manufacturer to analyse, specify, develop, and evaluate the usability of a medical device as it relates to safety. Applies to all medical devices but especially important for Class II and above. $5K – $20K 6 markets US (FDA)EU (MDR)CanadaAustralia (TGA)Japan (PMDA)Singapore (HSA) | |||||
IEC 60601-1 | Electrical Safety & Essential Performance | Optional | US (FDA)EU (MDR)Canada+5 | $10K – $50K | |
IEC 60601-1 OptionalElectrical Safety & Essential PerformanceGeneral requirements for basic safety and essential performance of medical electrical equipment. Includes collateral and particular standards for specific device types. $10K – $50K 8 markets US (FDA)EU (MDR)CanadaAustralia (TGA)Japan (PMDA)China (NMPA)South Korea (MFDS)Singapore (HSA) | |||||
IEC 62304 | Software Lifecycle Processes | Optional | US (FDA)EU (MDR)Canada+6 | $20K – $80K | |
IEC 62304 OptionalSoftware Lifecycle ProcessesDefines the lifecycle requirements for the development of medical device software and software within medical devices. Covers software development planning, requirements, architecture, implementation, testing, and maintenance. $20K – $80K 9 markets US (FDA)EU (MDR)CanadaAustralia (TGA)Japan (PMDA)China (NMPA)South Korea (MFDS)Singapore (HSA)India (CDSCO) | |||||
IEC 81001-5-1 | Health Software Security | Optional | US (FDA)EU (MDR)Canada+4 | $15K – $50K | |
IEC 81001-5-1 OptionalHealth Software SecurityRequirements for the security activities in the product lifecycle of health software. Covers threat modelling, secure design, vulnerability management, and security testing. Increasingly required under EU MDR and FDA cybersecurity guidance. $15K – $50K 7 markets US (FDA)EU (MDR)CanadaAustralia (TGA)Japan (PMDA)South Korea (MFDS)Singapore (HSA) | |||||
ISO 11607 | Packaging for Terminally Sterilized Devices | Optional | US (FDA)EU (MDR)Canada+5 | $5K – $15K | |
ISO 11607 OptionalPackaging for Terminally Sterilized DevicesRequirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems. Ensures sterile barrier integrity is maintained until point of use. $5K – $15K 8 markets US (FDA)EU (MDR)CanadaAustralia (TGA)Japan (PMDA)China (NMPA)South Korea (MFDS)Singapore (HSA) | |||||
ISO 11135 / 11137 | Sterilization Processes | Optional | US (FDA)EU (MDR)Canada+5 | $15K – $40K | |
ISO 11135 / 11137 OptionalSterilization ProcessesISO 11135 covers sterilization by ethylene oxide, while ISO 11137 covers radiation sterilization. Defines requirements for the development, validation, and routine control of sterilization processes. $15K – $40K 8 markets US (FDA)EU (MDR)CanadaAustralia (TGA)Japan (PMDA)China (NMPA)South Korea (MFDS)Singapore (HSA) | |||||
ISO 18113 | IVD Labelling & Information | Optional | US (FDA)EU (IVDR)Canada+4 | $3K – $8K | |
ISO 18113 OptionalIVD Labelling & InformationSpecifies labelling requirements for in vitro diagnostic medical devices and reagents. Covers labelling for reagents, specimen receptacles, instruments, and self-testing products. $3K – $8K 7 markets US (FDA)EU (IVDR)CanadaAustralia (TGA)Japan (PMDA)China (NMPA)Singapore (HSA) | |||||
ISO 20916 | IVD Clinical Performance Studies | Optional | US (FDA)EU (IVDR)Canada+3 | $50K – $300K | |
ISO 20916 OptionalIVD Clinical Performance StudiesProvides requirements for the design, conduct, and reporting of clinical performance studies for in vitro diagnostic medical devices. Required under EU IVDR and increasingly referenced globally. $50K – $300K 6 markets US (FDA)EU (IVDR)CanadaAustralia (TGA)Japan (PMDA)China (NMPA) | |||||
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Cost estimates are approximate and vary by testing laboratory, device complexity, and geography. This matrix is for guidance only and does not constitute regulatory advice.