Regulated software development
Software built to survive the audit
SoftSoft is a software development group for organisations that answer to regulators. We deliver clinical, laboratory, financial and public systems with the design controls, validation evidence and documentation the framework requires, produced alongside the code.
12
Years delivering into regulated environments
180+
Audited releases shipped under formal change control
60
Engineers, QA and quality specialists
14
Regulatory frameworks covered across four sectors
Services
Engineering and evidence, delivered together
Every engagement is scoped against a named regulatory target. The deliverable is a working system and the documented proof that it was built, tested and released under control.
Regulated product engineering
End-to-end delivery of clinical, diagnostic and enterprise platforms, engineered from day one against the standards your auditors will apply.
Medical device software (SaMD)
Software as a medical device developed under IEC 62304 with classification support, risk management files and design history documentation.
Verification & validation
Traceable test strategies, automated regression suites, IQ/OQ/PQ protocols and executable evidence that maps requirement to result.
Quality management documentation
SOPs, design controls, traceability matrices and technical files produced alongside the code rather than reconstructed before an audit.
Legacy system modernisation
Migration of validated legacy systems to supported architectures without losing regulatory status or operational continuity.
Compliance-trained delivery teams
Dedicated engineers who already work inside quality systems, integrating with your QMS, change control and release governance.
Industries
We work where the rules are written down
Healthcare & medtech
Clinical systems, connected devices and software as a medical device.
Pharma & life sciences
Validated systems for manufacturing, laboratory and clinical operations.
Financial services
Payment, lending and compliance platforms under supervisory scrutiny.
Public sector
Citizen services with residency, accessibility and procurement obligations.
Compliance
Frameworks we build against
Standards enter the backlog on day one as requirements. Each applicable clause is mapped to a control, an owner and a piece of evidence.
Medical device & health
- IEC 62304
- ISO 13485
- ISO 14971
- EU MDR / IVDR
- HIPAA
- HL7 FHIR
Life sciences
- GxP
- GAMP 5
- FDA 21 CFR Part 11
- Annex 11
- CSV / CSA
Information security
- ISO/IEC 27001
- SOC 2 Type II
- NIST SSDF
- OWASP ASVS
Data & financial
- GDPR
- PCI DSS
- PSD2 / SCA
- AML / KYC controls
Process
A lifecycle that produces its own audit trail
Discovery & regulatory gap analysis
We establish the applicable framework, intended use and classification, then map the distance between where your product is and where the regulation requires it to be.
Requirements & risk management
User needs, system requirements and hazard analysis are captured in a single traceable structure that survives scope change.
Design controls
Architecture, interface and security design are reviewed and recorded as controlled outputs, with decisions justified against risk.
Verified development
Engineering runs under change control: reviewed commits, automated pipelines, static analysis, SBOM generation and evidence captured per build.
Validation & documentation
Verification reports, validation protocols and the technical file are assembled as deliverables, ready for notified body or internal audit review.
Post-market support
Surveillance, vulnerability monitoring, CAPA support and controlled maintenance releases across the supported lifetime of the product.
Engagement models
Dedicated team
A stable, compliance-trained squad embedded in your delivery organisation and governed by your quality system.
From 4 specialists · 6 months minimum
Project delivery
Fixed-scope delivery of a product or module against an agreed regulatory target, with documentation as a contractual deliverable.
Scoped after gap analysis
Audit & remediation
Independent assessment of an existing system, its documentation and its gaps, followed by a prioritised remediation programme.
2–6 week assessment
Insights
Notes from the regulated delivery floor
Traceability without spreadsheets
A requirements traceability matrix maintained by hand is already out of date. We generate ours from the tools the team already uses.
Dana Yerzhanova
Reading IEC 62304 safety classification honestly
Safety class follows from the harm a failure can cause. Teams read it as a measure of complexity and pay for that at submission.
Marat Iskakov
Validating a CI pipeline in a GxP environment
Unvalidated automation is the compliance risk. A qualified pipeline carries more evidence than any manual process ever did.
Aliya Sultanova
Questions
Before the first call
Contact
Start with a regulatory gap analysis
Describe the system, the market and the framework you are held to. We reply with an assessment scope, timeline and the documentation you would receive.
General enquiries
hello@softsoft.kzAudit & compliance
compliance@softsoft.kz