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
Regulatory Strategy and Support
Consultancy to determine regulatory pathways, identify regulatory risks, and define compliance strategies for medical device software products.
Quality Management System Implementation
Design and implementation of quality management systems for medical device software, including ISO 13485 alignment and internal audit services.
Medical Device Engineering Support
Engineering support for developing and maintaining medical device software according to recognized engineering and regulatory best practices.
Regulatory Documents and Submission Support
Preparation, maintenance and gap assessment of regulatory documentation and support for submissions required for medical device certification.
Testing and Development Expert Services (Network-Based)
Access to a network of testing providers and subject-matter experts to perform verification, validation and other testing activities for digital health products.
Cybersecurity and Information Security Compliance
Combined cybersecurity technical support and compliance alignment with privacy and security frameworks such as GDPR and ISO 27001 for medical device software.
Regulatory Strategy and Support
Consultancy to determine regulatory pathways, identify regulatory risks, and define compliance strategies for medical device software products.
Quality Management System Implementation
Design and implementation of quality management systems for medical device software, including ISO 13485 alignment and internal audit services.
Medical Device Engineering Support
Engineering support for developing and maintaining medical device software according to recognized engineering and regulatory best practices.
Regulatory Documents and Submission Support
Preparation, maintenance and gap assessment of regulatory documentation and support for submissions required for medical device certification.
Testing and Development Expert Services (Network-Based)
Access to a network of testing providers and subject-matter experts to perform verification, validation and other testing activities for digital health products.
Cybersecurity and Information Security Compliance
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