We’re Experts in Software as Medical Devices

Our team has expertise with Digital Health and Artificial Intelligence (AI) across Europe and the USA, and are part of international networks, to bring you the most updated knowledge and practice to the future of Medical Devices (MD) and In-Vitro Diagnostic (IVD).

MD/IVD Regulatory and Compliance Consultancy

Complear offers expertise on Software, providing complete regulatory affairs and quality support services to manufacturers and distributors of medical devices. We work as extended team members from the idea stages of the products up to reaching the market.

We can start from the determination of the appropriate regulatory submission requirements and strategies for new or modified products, guide full development of a compliant product, implementation Quality Management Systems, filing in different global geographies, and finally, we can provide continuous product and strategy update and give access to the top regulatory intelligence support. Our work leverages a global network of experts that can support each technology and need of the companies we work with.

Regulatory Strategy & Support
Support Technical Documentation
Support Quality Management System and Standards
ISO 13485, ISO 14971, IEC 62304, IEC 62366, …

We’re Changing the Way for Full Compliance

We believe that in the future regulatory and compliance will be mostly powered by automation and community intelligence

Our Automated Regulatory and Compliance Platform

Complear is building the future operating system for automating regulatory and compliance for Digital Health. Complear provides a digital platform that allows teams to bring quality Software as Medical Device to market, keeping lean on Planning, Regulatory Compliance and Quality Management from day one.

Currently in Private Beta.

Scenarios for new products or new features to understand compliance implications
Product Definition
Design & Development and Risk Management for a new product development
Electronic Documentation
Electronic Documentation with Regulatory Intelligence
Training Module according to your needs

We’re Here To Help You

Get in touch with us today and let’s start with your regulatory and quality compliance!

Contact us