Medical Device Software Consulting

Regulatory, compliance, and software lifecycle experts.

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We help Australian medical device companies navigate TGA and FDA requirements. Our consulting ensures your software meets the expectations of regulators.

Written for CTOs, regulatory leads, and health tech founders focused on compliance and software lifecycle best practices.

Regulatory Gap Analysis

IEC 62304
ISO 14971
ISO 13485
IEC 60601-1

TGA & FDA Readiness

Cybersecurity, HIPAA, Privacy Act

Software Development Support

Review, test and improve existing software

How We Work

1. Free discovery session — We learn about your software, regulatory context, and market.

2. Gap analysis and proposal — Receive a clear plan outlining what’s required and why.

3. Compliance implementation — We create documents, update SOPs, fix gaps, and provide hands-on guidance.

4. Audit readiness — Full support through TGA or FDA submission.

Who This Is For

You’re building a Medical Device with Software or Software as a Medical Device (SaMD).

You need to meet these standards: IEC 62304, ISO 14971, IEC 60601-1, ISO 13485, TGA requirements, FDA 510(k), or cybersecurity in medical devices.

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Boost Design - Case Study

Industry: Product Development

Problem: Needed specialist assistance with a large medical software and compliance project.

Solution: Guided IEC 62304 and cybersecurity compliance. Coordinated verification testing, regression analysis, code reviews and unit tests. Assisted with updates to SOPs and documentation.

Result: Completed the project through to client delivery.