By Maruthachala Ponnambalam, Founder & CEO, Srushty Global Inc

With AI, IoT, and smart sensors becoming integral to modern medical devices, FDA compliance has emerged as a key challenge for hardware developers and MedTech startups. Unlike traditional software products, IoT-enabled medical devices must meet stringent regulatory requirements to ensure patient safety, data integrity, and long-term viability. I recently had an insightful discussion with Dr. Satyender Goel, Founder & CEO of India Health Link, on my podcast Creations Engineered. We explored IoT medical devices and delved deep into the MedTech industry.

The complexities of design validation, cybersecurity, and regulatory approval can often overwhelm early-stage startups. However, with the right approach, navigating FDA compliance can become a structured and strategic process rather than an obstacle.

Beyond compliance, another critical factor in medical device success is user centricity. A device must not only meet regulatory standards but also be intuitive, accessible, and seamlessly integrated into healthcare workflows. 

As Dr. Satyender Goel pointed out in our discussion, “A great medical device isn’t just about passing regulations; it has to be designed for real-world users, patients, doctors, and healthcare providers. Compliance and usability must go hand in hand.”

Understanding FDA Regulatory Requirements for IoT Medical Devices

The U.S. Food and Drug Administration (FDA) classifies medical devices into three categories based on risk level:

• Class I (Low Risk) – Minimal regulatory oversight (e.g., digital thermometers)
• Class II (Moderate Risk) – Requires FDA clearance (e.g., wearable glucose monitors)
• Class III (High Risk) – Requires rigorous FDA approval, including clinical trials (e.g., implantable heart devices)

For IoT medical devices, compliance is particularly critical in three areas:

1. Software as a Medical Device (SaMD)

While FDA does not explicitly enforce IEC 62304, compliance with this standard demonstrates strong software development practices.

2. Cybersecurity & Data Integrity

FDA’s cybersecurity guidelines emphasize risk management, software bill of materials (SBOM), secure product development frameworks, post-market updates, and patches. IoT devices must comply with HIPAA, IEC 80001-1, and FDA’s Cybersecurity Guidelines to protect patient data.

“Medical device safety isn’t just about hardware, it’s also about the software running on it. Every single line of code must be accounted for in the Software Bill of Materials (SBOM), ensuring compliance and security.” – Dr. Satyender Goel

3. Quality Management System (QMS)

Startups must implement a robust QMS, in line with ISO 13485, to track design, development, production, distribution, and post-market surveillance.

Best Practices for Hardware & Software Validation to Meet Compliance

1. Integrate Compliance from Day One

Many startups make the mistake of treating compliance as an afterthought. FDA regulations should be embedded in the design and development process from the very beginning. This includes:

• Establishing design controls to document key engineering decisions.
• Implementing ISO 13485-compliant QMS for product reliability.
• Adopting SBOM to meet FDA’s software validation expectations.

2. Subject Matter Expertise for Compliance

Since regulatory compliance is complex, involving Subject Matter Experts (SMEs) early can avoid costly mistakes. Many successful MedTech companies streamline compliance by working with regulatory specialists from the beginning.

Compliance isn’t something you add at the end, it has to be part of the journey from day one, just like your functional prototype or hardware.

3. Hardware Validation: Prototyping and Testing

Medical device validation goes beyond functional prototypes. Best practices include:

• Iterative prototyping: Test components early to identify design flaws.
• Benchmarking against gold standards: Compare device accuracy with existing FDA-approved devices.
• Clinical trials and ethical approvals: Collaborate with hospitals to validate device performance in real-world settings.

4. Software Validation: Continuous Testing & Security Measures

Unlike hardware, software development is an ongoing process. FDA compliance requires startups to:

• Validate firmware and embedded software updates before deployment.
• Implement traceability matrices to map software requirements to test cases.
• Follow IEC and NIST standards for cybersecurity.

A well-coordinated approach between hardware and software teams ensures seamless integration and minimizes compliance risks.

5. Documentation and Traceability

FDA audits require comprehensive documentation covering the entire development lifecycle. Key documents include:

• Design History Files (DHF) detailing product evolution.
• Device Master Records (DMR) for manufacturing consistency.
• Validation and Verification Reports ensuring performance and safety.

A well-maintained documentation trail facilitates regulatory approval and accelerates market entry.

6. Budgeting for Compliance

Compliance isn’t cheap, but early planning prevents expensive rework. Startups should:

• Allocate budget for certification, audits, and SME consultations.
• Factor in compliance-related manufacturing costs.
• Prepare for potential delays in approval processes.

By following these best practices, startups can streamline validation, reduce compliance risks, and accelerate market entry while maintaining the highest safety standards.

Common Pitfalls & How to Avoid Them

Mistake 1: Treating Compliance as an Afterthought

Startups often focus on product innovation while ignoring regulatory requirements until later stages.
Solution: Integrate regulatory roadmaps into the product development cycle from day one.

Mistake 2: Underestimating Cybersecurity Risks

Medical IoT devices are prime targets for cyberattacks, leading to patient safety risks.
Solution: Conduct regular security audits, implement role-based access control, and follow FDA cybersecurity protocols.

Mistake 3: Delayed Clinical Trials & Market Validation

Many startups overlook early clinical testing, leading to costly delays.
Solution: Initiate pilot studies in healthcare settings before full-scale trials.

Compliance is not just a requirement but a strategic advantage that builds trust and accelerates approvals. Startups should integrate regulatory planning from day one, working with compliance experts to avoid costly mistakes. Cybersecurity must be a priority, as FDA regulations on data integrity and AI transparency continue to evolve. Testing early and iterating often through real-world validation enhances device reliability and increases the chances of approval. By embedding compliance into the development process from the start, MedTech startups can streamline their path to market and scale with confidence.