QMS, Quality & Regulatory

Strategic Guidance To Our Clients

Tridios is a leading provider of Contract Development and Manufacturing Services for the health-tech industry. In addition to our clinical services, we offer our clients strategic guidance at every stage of the product development process. Our regulatory experts have extensive experience in multiple regulatory jurisdictions, including MDSAP (Australia, Brazil, Canada, Japan, United States), EU MDR, and more.

Quality By Design Principles

At Tridios, with a focus on Regulatory Affairs, Quality Assurance, QMS, GMP, SaMD & Artificial Intelligence, Software Validation and Software Life Cycle Management, IT Security and cybersecurity, Drug-Device Combination, Design and development, FMEA, Risk Management, Usability Engineering, Industrial Manufacturing, Commercial scale up, PMCF, Clinical Evaluation and Clinical Studies, we are a company driven by risk-based approach and quality-by-design principles.

High-Quality Regulatory Services

A few of the technologically advanced medical device markets in which we are active include SaMD/MDSW or SaMD + Active Devices, Artificial Intelligence based devices, Ophthalmology, Wearables, wound care, Digital Health (Digital Health Platform) At Tridios, we are committed to providing our clients with high-quality regulatory services that are tailored to meet their specific needs.

QMS

We provide guidance on developing and implementing a Quality Management System that meets regulatory requirements. Our team has extensive experience in designing and implementing QMS (ISO 13485) that meets the requirements of various regulatory jurisdictions.

MDSAP

We provide support for MDSAP audits, which are required for companies that sell medical devices in multiple countries. Our team can help you prepare for and pass MDSAP audits, ensuring that your products meet the regulatory requirements of the countries where they are sold.

Full regulatory support

We offer full regulatory support for UKCA / CE / FDA approvals. Our regulatory experts can help you navigate the complex regulatory landscape and ensure that your products meet the requirements for approval in the countries where you plan to sell them.

Compliance

We provide guidance on compliance with regulatory requirements, including the Medical Device Regulations, EU MDR, and FDA requirements. Our team can help you ensure that your products meet the requirements for safety and effectiveness.

Competent Team

The Tridios team is competent in working with new businesses, start-ups, etc., to obtain certifications like ISO 13485 and MDSAP, or even provide assistance to achieve marketing approvals and licenses. We even help with various compliance testing such as IEC 60601, ISO 10993, IEC 62304/82304, ETSI, ASTM, and more.