Regulatory Compliance & Affairs
Engineer for the requirements. From day one.
Regulatory strategy should not arrive after the product has been built. We integrate regulatory, quality, safety, cybersecurity and documentation considerations into the engineering lifecycle of HealthTech and MedTech products.
Requirements → Regulations
Compliance is an engineering input — not a final checklist.
For medical software and devices, product architecture, intended use, risk, quality processes, verification and technical documentation are interconnected. Codexter Labs brings those considerations into product development so teams can make informed engineering decisions earlier.
Our role is to help engineer the product and its supporting evidence toward the applicable requirements — not to promise regulatory approval.
Our regulatory engineering model
Build the product. Build the evidence. Keep the two connected.
Define
Product classification
Establish the intended use, users, environment, product boundaries and target-market assumptions.
- Intended-use inputs
- Product scope
- Regulatory questions
Control
Requirements & risk analysis
Translate product needs into structured requirements and risk-aware engineering inputs.
- Requirements
- Risk considerations
- Design controls
Verify
Engineering evidence
Create testable requirements and verification activities that demonstrate whether the implemented system behaves as specified.
- Verification plans
- Test protocols
- Traceability
Document
Technical baseline
Organize the technical record and development artifacts needed for the applicable product lifecycle.
- Technical documentation
- Change records
- Release baseline
Designed around your target market.
The applicable pathway depends on the product, intended use, classification, claims, technology and jurisdiction. Our engineering and regulatory work can support development contexts involving the following frameworks and standards.
United States
US FDA
Engineering and documentation considerations can be aligned to the applicable FDA pathway and device/software context.
European Union
EU MDR / CE
Support product engineering with the technical, risk and documentation considerations relevant to the applicable European pathway.
Saudi Arabia
SFDA
Consider Saudi-market requirements within product planning and the broader regulatory strategy.
Medical Software
SaMD / SiMD
Engineering support for software as a medical device and software-integrated medical-device contexts.
Device classification → Device Registration
End-to-end regulatory support. Technical file preparation to submission compliance and registration.
Quality Management
ISO 13485
Quality-system considerations can be integrated into the development process and supporting documentation.
Medical Software
IEC 62304
Software lifecycle considerations for applicable medical-device software development contexts.
Risk Analysis
ISO 14971
Risk-management considerations can be integrated into the medical-device development process and supporting documentation.
Information Security
ISO 27001
Security governance and information-security controls for connected HealthTech environments.
Electrical Safety
IEC 60601
Engineering considerations for applicable medical electrical equipment and system development contexts.
Regulatory engineering follows the product lifecycle.
Rather than creating a compliance workstream that operates separately from engineering, we connect regulatory inputs to the stages where product decisions are actually made.
Intended use
Define what the product is intended to do and for whom.
Classification inputs
Identify the questions that influence the applicable
pathway.
Requirements
Convert product and
regulatory inputs into engineering requirements.
Risk & design
Connect risks, controls and design decisions.
Verification
Generate objective evidence against defined requirements.
Technical baseline
Maintain the documentation and evidence needed for the next stage.
what we do
Where we contribute.
Our regulatory capability is most valuable when it is embedded in technical product development rather than treated as a document-production exercise.
01 Regulatory pathway support
Structure early regulatory questions around intended use, product characteristics, target markets and technology so engineering decisions are made with the destination in view.
02 Requirements & traceability
Create a logical connection between user needs, system requirements, design elements, implementation and verification evidence.
03 Software lifecycle engineering
Support structured development of medical software, including architecture, requirements, implementation, testing, release and maintenance considerations.
04 Cybersecurity & connected products
Address security architecture, access control, data protection, interfaces, update considerations and connected-system dependencies.
04 Technical documentation
Organize engineering outputs, design records, verification evidence and product information into a coherent technical baseline.
Submission Clearances & Global Reach
Global Market Authorization Matrix
Regulatory Body
Scope & Pathways Handled
Key Deliverables
US FDA
510(k) Premarket Notifications (Traditional, Special, Abbreviated), De Novo Classifications, Q-S ubmissions / Pre-Subs, and FDA QMSR (21 CFR Part 820) alignment.
- Substantial Equivalence (SE) determination
- Full eSTAR technical file compilation
- Software/Cybersecurity premarket packages
- RTA (Refuse to Accept) de-risking
European Union (CE MDR)
EU MDR 2017/745 conformity assessments across Class I, IIa, IIb, and III active medical devices, SaMD, and connected hardware.
- General Safety & Performance Requirements (GSPR) matrices
- Clinical Evaluation Plans/Reports (CEP/CER)
- Post-Market Surveillance (PMS) plans
- Notified Body technical audit support
Saudi FDA (SFDA)
Medical Device Marketing Authorization (MDMA) pathways, Kingdom-specific classification, and Authorized Representative (AR) liaison services.
- Technical documentation tailored to SFDA guidelines
- GHAD portal registration management
- Label harmonization
- Import clearance documentation
ISO 13485:2016 Quality Systems (QMS)
ISO 13485:2016 establishment and continuous compliance, alongside ISO 14971:2019 risk lifecycle execution.
- Complete SOP development
- Design History Files (DHF),
- Device Master Records (DMR)
- Device History Records (DHR) frameworks
- Mock audit defense
What this means for your team.
Regulatory engineering is about reducing avoidable rework and creating a product development process that can produce credible technical evidence.
For an early-stage product
We help identify regulatory questions before architecture and claims become difficult to change, while keeping the initial engineering proportional to the product stage.
For an existing prototype
We can assess the current technical baseline, identify gaps and create a structured roadmap toward a more controlled product-development process.
For a product in development
We integrate requirements, risk, verification, cybersecurity and documentation activities into the engineering workflow.
For a scaling product team
We help establish repeatable engineering practices, documentation structures and technical ownership that support future product iterations.
Let's map the requirements before they become rework.
Bring us your product concept, prototype or existing system. We’ll help identify the engineering, documentation and regulatory considerations that should shape the next development stage.