Regulatory Compliance

Technical File Preparation

We prepare and maintain complete, audit-ready technical documentation that supports regulatory submissions and product lifecycle management. Our technical file services include device description, intended use, design verification and validation data, risk analysis, software and hardware documentation, and labeling. Every document is structured to meet EU MDR Annex II and III or FDA 510(k)/PMA submission requirements. We ensure traceability and version control so your files withstand scrutiny from notified bodies and regulatory auditors.

Clinical Evaluation Report (CER)

Our experts produce robust, evidence-based Clinical Evaluation Reports that demonstrate the safety and performance of your medical device. Using literature review, real-world data, and post-market surveillance inputs, we generate CERs in compliance with EU MDR Article 61 and MEDDEV 2.7/1 Rev 4. Whether you’re launching a new device or updating an existing CER, we ensure the report clearly establishes clinical benefit, risk-benefit ratio, and conformity with General Safety and Performance Requirements (GSPRs).

Biological Evaluation Report (BER)

We conduct and compile Biological Evaluation Reports as per ISO 10993 standards to evaluate the biocompatibility of your medical device. Our approach includes gap analysis, toxicological risk assessments, and biological testing strategies, tailored to your device’s materials, duration of contact, and anatomical interface. This report is critical for Class II and III devices and a key requirement for global market access — we ensure it’s both scientifically sound and regulator-ready.

Implementation of Quality Management System (QMS)

We assist organizations in establishing and implementing a robust Quality Management System tailored to medical device development. Our services encompass the creation of SOPs, forms, templates, training programs, and internal audit mechanisms — all structured to meet ISO 13485:2016 standards. From startups needing a scalable QMS to mature companies seeking optimization, we ensure your system fosters continuous improvement, process consistency, and regulatory alignment.

ISO 13485 Compliance and Certification

Achieving ISO 13485 certification is a cornerstone of medical device quality assurance. We guide you step-by-step through the process — from initial gap analysis and documentation development to internal audits and certification support. Our team ensures your processes, design controls, production, and post-market surveillance systems meet the stringent requirements of ISO 13485:2016, providing a solid foundation for both domestic and international commercialization.

ISO 14971: Risk Management

Risk management is central to device safety and regulatory acceptance. We implement ISO 14971-compliant risk management systems that identify, evaluate, control, and monitor risks throughout your product’s lifecycle. Our team facilitates risk assessments like FMEA, FTA, and hazard analyses, integrates them into your design process, and ensures they are aligned with technical documentation, usability engineering, and post-market surveillance data.

Software as a Medical Device (SaMD)

Developing SaMD involves a nuanced understanding of software architecture, clinical intent, and regulatory obligations. We specialize in the end-to-end development and regulatory submission of SaMD under frameworks like FDA guidance, EU MDR Annex VIII, and IMDRF definitions. Our process includes software lifecycle documentation (aligned with IEC 62304), clinical evaluation, cybersecurity controls, and usability validation — ensuring your digital health solution meets safety, performance, and regulatory expectations.We perform rigorous packaging integrity tests including seal strength, burst, dye penetration, and microbial barrier assessments. These ensure sterility, safety, and compliance with ISO 11607 and FDA packaging guidelines.