Complete Documentation & Regulatory Guidance
At Soltech, we know that navigating the regulatory landscape is one of the most challenging parts of bringing a medical device to market. That’s why we don’t just build products — we deliver complete documentation packages that cover every stage of development, from initial design and risk analysis to verification, validation, and final production records.

Throughout the development process, we help prepare and maintain documentation to ensure full compliance with MDR 2017/745 Annex I (General Safety and Performance Requirements), Annex II (Technical Documentation), and ISO 13485:2016 Section 7.3 on design and development controls. Our approach ensures that all required design inputs, design outputs, verification and validation activities, usability evaluations, and risk management files are properly documented and traceable.

Our team ensures that all technical files, test reports, and quality documentation are developed to meet international standards and regulatory expectations. Beyond documentation, we guide you through the complete pathway toward CE marking or FDA clearance — helping you interpret complex requirements, avoid costly delays, and move forward with confidence.

To secure robust and compliant documentation, we work according to recognized technical standards relevant to your product, including:

· ISO 14971 – Risk management for medical devices

· IEC 62366-1 – Usability engineering

· IEC 60601 series / IEC 61010 series – Electrical and safety testing (where applicable)

· IEC 62304 – Software development lifecycle for medical device software

· ISO/IEC 27001 & IEC 81001-5-1 – Information security and health software cybersecurity (where applicable)

By combining engineering expertise with regulatory know-how, Soltech ensures your medical device is not only functional and safe but also fully compliant and ready for market launch.