Complear
Complear is a company dedicated to helping bring medical device software to the market by providing digital health regulatory and quality compliance solutions. They are building the future operating system for automating regulatory and compliance processes for Digital Health, leveraging automation and community intelligence. Their services include regulatory strategy support, quality management systems, medical device engineering, regulatory documentation, testing, cybersecurity, and training. They partner with digital health companies to navigate regulatory pathways and bring products to market efficiently. The company is involved in various projects, collaborations, and community networks to support innovation in healthcare technology.
Industries
Nr. of Employees
small (1-50)
Products
Automated regulatory and quality compliance platform
A digital platform that centralizes planning, regulatory compliance and quality management for medical device software, with modules for product strategy, AI-assisted documentation generation, and planned electronic technical documentation and eQMS functionality.
Automated regulatory and quality compliance platform
A digital platform that centralizes planning, regulatory compliance and quality management for medical device software, with modules for product strategy, AI-assisted documentation generation, and planned electronic technical documentation and eQMS functionality.
Services
Consultancy to determine regulatory pathways, identify regulatory risks, and define compliance strategies for medical device software products.
Design and implementation of quality management systems for medical device software, including ISO 13485 alignment and internal audit services.
Engineering support for developing and maintaining medical device software according to recognized engineering and regulatory best practices.
Preparation, maintenance and gap assessment of regulatory documentation and support for submissions required for medical device certification.
Access to a network of testing providers and subject-matter experts to perform verification, validation and other testing activities for digital health products.
Combined cybersecurity technical support and compliance alignment with privacy and security frameworks such as GDPR and ISO 27001 for medical device software.
Consultancy to determine regulatory pathways, identify regulatory risks, and define compliance strategies for medical device software products.
Design and implementation of quality management systems for medical device software, including ISO 13485 alignment and internal audit services.
Engineering support for developing and maintaining medical device software according to recognized engineering and regulatory best practices.
Preparation, maintenance and gap assessment of regulatory documentation and support for submissions required for medical device certification.
Access to a network of testing providers and subject-matter experts to perform verification, validation and other testing activities for digital health products.
Combined cybersecurity technical support and compliance alignment with privacy and security frameworks such as GDPR and ISO 27001 for medical device software.
Expertise Areas
- Regulatory strategy and market access for medical device software
- Quality Management System (ISO 13485) implementation
- Medical device software engineering and lifecycle support
- Cybersecurity and data protection compliance for digital health
Key Technologies
- AI-driven documentation generation and validation
- Electronic Quality Management Systems (eQMS)
- Automated electronic Technical Documentation (eTD)
- Digital/regulatory compliance platforms
News & Updates
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Women TechEU
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TB4Health Project
A testbed in the health and biotechnology sector providing infrastructure and technological capacity for developing and testing new health products and services. It aims to test 60 health-related digital products by September 2025.
PATH BOOTCAMP
A 10-week program supporting health tech startups in understanding European healthcare regulations and market access strategies.
INNOBUYER – MDR-prep
An innovative electronic QMS tool for compliance with Medical Device Regulation (MDR) for early-stage medical device development.
HealthChain Call for SMEs - Centro Portugal
A challenge addressing healthcare issues for the elderly and rehabilitation patients, proposing digital solutions like MediRecon for medication reconciliation.
Women TechEU
An EU-funded project supporting women leading deep tech startups in Europe, providing grants and resources to foster gender-balanced entrepreneurship.