MedTech certifications: What they are and why they matter

In the rapidly evolving landscape of medical technology, it’s essential to recognize that compliance with high standards for security, privacy, and quality in software development is not merely a formality—it’s a fundamental necessity. For founders and directors in the MedTech space, understanding these standards and certifications is crucial. They not only provide a framework for best practices but also help navigate the complex regulatory environment that governs our industry.

As you lead your teams in developing innovative healthcare solutions, prioritizing these standards will enhance your product’s credibility and trustworthiness. This commitment to excellence can significantly impact patient safety and data integrity, ultimately fostering a culture of accountability and reliability within your organization. By embracing these principles, you position your company not just to meet regulatory requirements but to excel in delivering secure and effective healthcare solutions that truly benefit patients and providers alike.

Below, we’ll walk through some of the key standards and certifications we follow, why they matter, and what it takes to comply with them.

ISO 27001 is an internationally recognized certification for managing information security. It sets requirements for establishing, implementing, maintaining, and continuously improving an information security management system (ISMS). This certification helps organizations protect data from threats like cyberattacks and breaches.

• Why it matters: For MedTech companies, protecting sensitive patient data is non-negotiable. ISO 27001 certification demonstrates that a company has a structured approach to handling security risks and safeguarding information.
• How to get certified with ISO 27001: The process involves a detailed risk assessment, implementing security controls, employee training, internal audits, and an external audit by a certification body.

ISO 27018 focuses on protecting personally identifiable information (PII) in cloud computing. It builds on ISO 27001 but is specifically tailored to cloud service providers handling sensitive personal data.

• Why it matters: Many healthcare applications rely on cloud infrastructure. This certification ensures that cloud-based services follow strict guidelines to protect user privacy and comply with regulations like GDPR.
• How to get certified with ISO 27018: Organizations must implement privacy-enhancing measures, perform risk assessments, and undergo an independent audit.

ISO 13485 is the go-to certification and standard for companies developing medical devices and software that supports them. It sets requirements for a quality management system (QMS) that ensures products meet regulatory and customer requirements.

• Why it matters: Software classified as a medical device must meet strict safety and performance standards. ISO 13485 certification signals that a company has a reliable process for developing safe and effective MedTech solutions.
• How to get certified with ISO 13485: Companies must document their development processes, conduct risk management, and undergo a third-party audit to verify compliance.

IEC 62304 is an international standard that provides a framework for the software development lifecycle of medical devices. It outlines best practices for risk management, software design, testing, and maintenance.

• Why it matters: Developing medical software comes with significant risks. IEC 62304 ensures that developers follow structured, safe, and consistent practices throughout the software’s lifecycle.
• How to comply with IEC 62304: Companies must align their software development processes with IEC 62304 requirements and pass an independent audit if required by regulators.

UL 2900, developed by UL (formerly Underwriters Laboratories), is a series of cybersecurity standards that includes a set of general cybersecurity requirements for network-connected products (UL 2900-1), as well as specific guidelines for medical and healthcare systems (UL 2900-2-1), industrial control systems (UL 2900-2-2), and security and life safety signaling systems (UL 2900-2-3).

• Why it matters: Connected medical devices, such as remote monitoring tools, are increasingly targeted by cyber threats. Compliance with UL 2900 helps ensure these devices have strong security measures in place.
• How to comply with IEC 82304: Products undergo security testing, risk assessments, and evaluations by an accredited UL testing lab.

The General Data Protection Regulation (GDPR) is a legal framework that governs data privacy in the European Union. While not a certification, compliance with GDPR is required for companies handling EU citizens’ data.

• Why it matters: MedTech companies working internationally must comply with GDPR to protect patient privacy and avoid hefty fines.
• How to comply with GDPR 2016/679: Organizations must implement data protection measures, conduct impact assessments, and ensure user consent for data collection.

SOC 2 is a framework developed by the American Institute of CPAs (AICPA) to evaluate a company’s controls over security, availability, processing integrity, confidentiality, and privacy.

• Why it matters: For MedTech companies handling sensitive health data, SOC 2 certification reassures clients that security and privacy measures are in place.
• How to get certified with SOC 2 Type 1: A third-party auditor assesses whether a company’s internal controls align with SOC 2 requirements.

MedTech certifications are more than just compliance requirements—they are the foundation of building software that is secure, reliable, and trusted by both healthcare professionals and patients. For developers, having a working knowledge of these frameworks is key to making informed design and security decisions.

At HTD, we don’t just check regulatory boxes—we focus on creating technology that enhances patient care, supports clinical workflows, and integrates seamlessly with existing healthcare ecosystems. Our expertise in digital health and connected medical devices allows us to develop software that is not only compliant but also user-friendly and impactful.

By holding these certifications, we reaffirm our commitment to high-quality MedTech development. As the industry continues to evolve, we remain dedicated to pushing innovation forward while maintaining the highest standards of security, privacy, and performance. Together, we can build the future of healthcare technology.