Overview
Software sector: an overview of conformity processes
For software, conformity varies by the field of use: IEC 62304 applies to medical device software, DO-178C to aerospace, and ISO 26262 to automotive. On the enterprise side, ISO/IEC 27001 and SOC 2 are the standard answer to customer assurance requests.
How we work
Six steps from scope to certificate
Scope
We determine your product, target market and sector; the required legislation list is produced.
Quote
Testing and audit items are priced separately; the quote is delivered within 24 hours.
Sample / Planning
Sample requirements are shared, or an on-site audit is scheduled.
Testing & Audit
Testing or audit is carried out according to the method of the relevant standard.
Report & Document
A report is issued; if within certification scope, the process proceeds to the decision stage.
Maintaining the validation
Surveillance audits and legislative changes are tracked.
Product groups
Software sector: what do we test?
- 01Enterprise and cloud software services
- 02Embedded software and firmware
- 03Medical device software (SaMD)
- 04Industrial control software
- 05Mobile applications
Services
The work we carry out in this sector
From testing laboratories to inspection, surveillance, audit, verification and calibration β all the services the Software supply chain needs are under one roof.
All services
Standards
Standards referenced by the sector
Content is linked to standards based on the product's intended use, target market and technical characteristics.
- ISO 11607end product sterile barrier packaging
- ISO 11737-1determination of microbial load in medical devices
- ASTM F1980accelerated aging in packaging
- ASTM F88peeling resistance in sealing seam
- IEC 60601-1Basic safety in medical electrical devices
- IEC 60601-1-2electromagnetic compatibility in medical electrical devices
- IEC 62304medical device software lifecycle processes
- IEC 62366-1usability engineering in medical devices
- ISO 10993-10skin sensitivity assessment
- ISO 10993-11systemic toxicity
- ISO 10993-23irritation assessment
- ISO 10993-3genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-4evaluation of interaction with blood
- ISO 10993-5in vitro cytotoxicity
- CISPR 32emissions in multimedia devices
- MIL-STD-461electromagnetic interference in military systems
- CISPR 25Radio degradation of in-car components
- IEC 60601-1-2electromagnetic compatibility in medical electrical devices
- IEC 61000-3-2harmonic current emission
- IEC 61000-3-3voltage fluctuation and flicker
- IEC 61000-4-11voltage sag and short interruption immunity
- IEC 61000-4-2electrostatic discharge (ESD) immunity
- IEC 61000-4-3radiated RF field immunity
- IEC 61000-4-4rapid transient/burst (EFT) immunity
- IEC 61000-4-5sudden surge immunity
- IEC 61000-4-6conducted RF immunity
- ISO 10605electrostatic discharge in vehicles
- ISO 11452radiated field immunity in vehicles
Certification
Documents that enable your product to reach the market
Global Market Access
Software which market will you offer your product to?
Software when offering products to different markets, technical legislation, tests, documents and conformity requirements may vary by country and region.
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