Regulatory expertise
Deep knowledge of the standards and regulations that govern medical device software and electronics.
MDR
Medical Device Regulation 2017/745
The Medical Device Regulation defines the requirements for medical devices in the European market. It impacts software development, documentation and lifecycle management.
Discuss MDR →What is MDR?
EU MDR 2017/745 replaces MDD and defines requirements for medical devices on the European market, including classification, technical documentation, clinical evaluation and post-market surveillance.
Software under MDR
Software that qualifies as a medical device (SaMD) or is embedded in a medical device must comply with MDR, including IEC 62304 for software lifecycle and ISO 14971 for risk management.
How Zentis supports MDR compliance
Zentis supports companies from gap assessment through technical file preparation, architecture reviews, QMS alignment and notified body support, ensuring your device meets MDR requirements efficiently.
IEC 62304
Software lifecycle for medical devices
IEC 62304 defines the software lifecycle requirements for medical devices. It covers development, maintenance and risk management. Zentis applies IEC 62304 throughout software development to ensure traceability, safety and compliance.
Discuss IEC 62304 →What is IEC 62304?
IEC 62304 is the international standard that defines the lifecycle requirements for medical device software. It is required by both EU MDR and FDA.
Software safety classes
IEC 62304 defines three safety classes (A, B, C) based on severity of harm. Class C, software that could cause death, requires the most rigorous development and verification processes.
How Zentis applies IEC 62304
Zentis applies IEC 62304 throughout all software development engagements. Our processes are ISO 13485 certified and fully aligned with the standard's requirements across all safety classes.
FDA
21 CFR Part 820 & Software Guidance
FDA regulations define requirements for medical devices entering the US market. This includes software validation, documentation and quality processes. Zentis supports companies in aligning their software and processes with FDA expectations.
Discuss FDA →Key FDA requirements for software
FDA requires software validation under 21 CFR Part 820, design controls and, for SaMD, adherence to the FDA's Digital Health Center of Excellence guidance.
Quality System Regulation
The QSR requires manufacturers to establish and follow a quality system for the design, manufacture and distribution of medical devices. Zentis aligns its processes with these requirements.
How Zentis supports FDA submissions
Zentis supports companies in aligning software and processes with FDA expectations, from design history file documentation to software validation reports and risk management files.
Cybersecurity
Security for connected medical devices
Cybersecurity is one of the most pressing topics in medical device development today. Zentis Medical embeds security-by-design into your development lifecycle, helping you accelerate certification and launch.
Discuss cybersecurity →What we do
- Threat modelling and risk assessment
- Security-by-design embedded in the development lifecycle
- Secure architecture and design review
- Cyber Resilience Act impact and readiness
- Security documentation for technical files and notified bodies
How we work
Threat modelling
We identify realistic threats and vulnerabilities specific to your device and its connectivity.
Design & mitigation
Security controls built into the architecture, not bolted on afterwards.
Documentation
Security evidence and documentation ready for notified bodies and regulators.
FAQ
Why is cybersecurity suddenly so important for medical devices?
Connected devices are increasingly targeted, and regulation (MDCG 2019-16, the incoming EU Cyber Resilience Act) now requires demonstrable security by design.
Do you offer this as a standalone service?
Yes, as a focused engagement, or integrated into a development or compliance project.
Built around the standards that matter
ISO 13485
International standard for quality management systems in the medical device industry, covering design and development controls, verification, documentation and supplier control. Zentis is ISO 13485 certified by BSI.
MDR 2017/745
Defines requirements for all medical devices on the European market, including software classification, technical documentation, clinical evaluation and post-market surveillance.
IEC 62304
International standard for medical device software lifecycle processes, required by both EU MDR and FDA. Covers development planning, architecture, implementation, verification and maintenance.
ISO 14971
Risk management standard for medical devices, identifying, evaluating and controlling risks throughout the device lifecycle from design through post-market surveillance.
FDA 21 CFR
US Food and Drug Administration Quality System Regulation, required for medical devices entering the US market. Covers design controls, validation and post-market requirements.
IEC 60601
Electrical safety and EMC standard for medical electrical equipment, required for all powered medical devices. Covers basic safety and essential performance.
Need regulatory guidance?
We are happy to discuss your compliance challenges.
Feel free to contact us →