medicQA
medicQA is a medical device consulting company specializing in designing, maintaining, and managing quality management systems and regulatory affairs processes. Their mission is to help bring medical device products to market by providing creative, compliant solutions tailored to companies of all sizes. They focus on facilitating the establishment of compliant Quality Management Systems, project management, regulatory strategy development, and supporting certification processes. Founded in 2013, medicQA is committed to delivering flexible, customer-oriented guidance to ensure their clients' success in the medical device industry.
Industries
Nr. of Employees
small (1-50)
Products
Quality Management
Ensures your Quality Management System is running smoothly, allowing you to concentrate on your core business.
Quality Management System Establishment
Efficiently facilitate establishing a Quality Management System compliant to applicable regulation.
Medical Device Quality Management Consulting
Establish and maintain a robust Quality Management System compliant with a range of regulatory requirements tailored to specific company needs.
Medical Device Regulatory Strategy and Technical Documentation Services
Development of a complete regulatory strategy including device classification, regulatory requirements overview, technical documentation construction, and submission review.
Regulatory Affairs Management
Help you effectively determine and fulfill the regulations that apply to your device when bringing a new medical device to the market or introducing a device to new markets.
Medical Device Audit and Supplier Quality Services
Internal audit program execution, mock audits, external audit support, and comprehensive supplier quality management.
Quality Management
Ensures your Quality Management System is running smoothly, allowing you to concentrate on your core business.
Quality Management System Establishment
Efficiently facilitate establishing a Quality Management System compliant to applicable regulation.
Medical Device Quality Management Consulting
Establish and maintain a robust Quality Management System compliant with a range of regulatory requirements tailored to specific company needs.
Medical Device Regulatory Strategy and Technical Documentation Services
Development of a complete regulatory strategy including device classification, regulatory requirements overview, technical documentation construction, and submission review.
Regulatory Affairs Management
Help you effectively determine and fulfill the regulations that apply to your device when bringing a new medical device to the market or introducing a device to new markets.
Medical Device Audit and Supplier Quality Services
Internal audit program execution, mock audits, external audit support, and comprehensive supplier quality management.
Services
Design and deploy a customised QMS for medical device companies to meet applicable regulatory requirements, with staff workshops and training for adoption.
Develop market-entry strategies, classify devices, identify required documentation, prepare and review technical documentation for submissions.
Manage development projects or specific phases to coordinate stakeholders, maintain schedules and budgets, and insulate teams from non‑development distractions.
Provide lead-auditors to run internal audit programs, perform mock audits, and support clients during external certification audits.
Support supplier searches and qualification, develop supplier quality, and manage complaint handling and CAPA documentation and closure.
Design and deploy a customised QMS for medical device companies to meet applicable regulatory requirements, with staff workshops and training for adoption.
Develop market-entry strategies, classify devices, identify required documentation, prepare and review technical documentation for submissions.
Manage development projects or specific phases to coordinate stakeholders, maintain schedules and budgets, and insulate teams from non‑development distractions.
Provide lead-auditors to run internal audit programs, perform mock audits, and support clients during external certification audits.
Support supplier searches and qualification, develop supplier quality, and manage complaint handling and CAPA documentation and closure.
Expertise Areas
- Quality management systems (medical devices)
- Regulatory affairs and market approval strategy
- Medical device project management
- Technical documentation and design-phase support
Key Technologies
- Quality management systems (QMS)
- Regulatory strategy development
- Risk management (ISO 14971 style processes)
- Usability engineering and usability specifications