Turntiles
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Doctor interacting with holographic human body
Core Focus

MedTech software. Fully compliant.

From Class I to Class III medical devices, we help software and hardware manufacturers design, build, and deploy clinically valid healthcare platforms.

UK & EU MDR Compliance

We structure software development to align directly with Annex I General Safety and Performance Requirements (GSPRs) of the Medical Device Regulation.

  • ✔ ISO 13485 aligned documentation pathways
  • ✔ IEC 62304 software life-cycle processes
  • ✔ IEC 62366 usability engineering documentation

Information Security

MedTech platforms handle the most sensitive data. We build around defense-in-depth principles to satisfy international governance audits.

  • ✔ HIPAA & GDPR aligned database structures
  • ✔ NHS Data Security and Protection Toolkit (DSPT)
  • ✔ ISO 27001 aligned infrastructure management
Compliance Grid

Regulatory standards we implement

We build software that conforms to global healthcare rules, maintaining audit trails and documentation required by notified bodies.

Scope: Establishes global compliance policies for quality management systems in design, development, and manufacturing of medical software.

Our Engineering Controls: We maintain strict design history files (DHF), design controls, risk registers, and automated verification checks linked directly to the codebase to simplify notified-body audits.
STATUS: COMPLIANT & AUDIT-READY

Scope: Standardizes lifecycle activities (design, coding, unit testing, maintenance) for Class A, B, and C software as a medical device (SaMD).

Our Engineering Controls: Automated generation of software requirement trace matrices (mapping SRS to Git commits and unit tests), SOUP component tracking, and continuous integration pipeline validation logs.
STATUS: COMPLIANT & AUDIT-READY

Scope: Defines safety hazard metrics and software mitigation rules throughout the medical device lifecycle.

Our Engineering Controls: Threat modeling processes mapped directly in code as unit verification test paths. Every safety hazard has a corresponding coded validation check in the continuous deployment system.
STATUS: COMPLIANT & AUDIT-READY

Scope: Protects Protected Health Information (PHI) and Personal Data under strict EU and US privacy laws.

Our Engineering Controls: Advanced KMS envelope encryption structures, read/write audit logging on sensitive fields, automatic data masking, anonymization routines, and secure IAM credentials.
STATUS: COMPLIANT & AUDIT-READY
SaMD Classification

Software as a Medical Device Classification

Class I (Low Risk)

Software used for general health management, lifestyle monitoring, or simple logging systems.

Requires: General Controls

Class IIa / IIb (Medium Risk)

Diagnostic tools, EHR databases, and medical calculation software (equivalent to IEC 62304 Class B).

Turntiles Focus Area

Class III (High Risk)

Software controlling life-critical systems, implantables, or ICU delivery mechanisms.

Requires: Strict Pre-Market Approval