Freyrinc

Regulatory Strategy Consultation for SaMD focuses on guiding healthcare and digital health companies through the complex regulatory landscape governing Software as a Medical Device. It ensures that SaMD products meet compliance requirements while accelerating market approval and reducing regulatory risks.

QMS (Quality Management System) Consultancy Services help organizations design, implement, and maintain effective quality management systems that meet international standards like ISO 9001, ISO 14001, ISO 45001, and more. These services ensure your business processes are well-documented, efficient, and focused on continuous improvement.

QMS Remediation & Establishment Services help organizations design, fix, and strengthen their Quality Management System to meet regulatory and industry standards. Whether you are building a QMS from scratch or addressing gaps identified during audits, inspections, or compliance reviews, these services ensure your quality framework is effective, compliant, and sustainable.

Our Compliance, Audit, and Validation Services help organizations meet regulatory requirements, maintain operational integrity, and ensure consistent quality across processes and systems. We support businesses in navigating complex regulatory landscapes while minimizing risk and improving efficiency.

The ISO 13485:2016 Toolkit is a comprehensive, ready-to-use package designed to help medical device manufacturers and related organizations efficiently implement, manage, and maintain an ISO 13485–compliant Quality Management System (QMS). It provides structured templates, procedures, and records aligned with regulatory expectations and global best practices.

Supplier Evaluation is a systematic process used to assess and monitor suppliers based on their ability to meet quality, delivery, cost, and compliance requirements. It helps organizations select reliable vendors and maintain consistent product and service standards.

Our Comprehensive Biocompatibility Compliance Services for Medical Devices are designed to help manufacturers ensure their products meet international safety and regulatory standards. We support medical device companies in evaluating biological safety in accordance with ISO 10993 and global regulatory requirements, ensuring patient safety and regulatory approval.

A Medical Device Literature Search Protocol and Review is a structured process used to identify, analyze, and document scientific and clinical evidence related to a medical device’s safety, performance, and effectiveness. This process is essential for regulatory submissions, clinical evaluations, risk management, and post-market surveillance.