Systems adaptive
Connect regulatory
and quality work around your organization Bring quality management
into daily operations around your organization
Consulting and software to support development, quality and production.
From document systems to daily quality work and operational improvement, we work with you.
Meet MedQraft.
MedQraft provides medical device development, regulatory and quality consulting and quality and production workflow software for your organization.
From early development to regulatory strategy for domestic and overseas markets, technical documentation, test planning, product authorization and GMP audit preparation, we identify the work needed at your current stage together with you.
Document and regulatory reviews following product changes also consider development, regulatory and quality requirements together in defining our support.
Your organization can choose consulting and software independently according to its needs.
Market-specific regulatory review and product feature scope are explained separately.
Any integrations needed are reviewed individually.
MedQraft provides ISO 9001 and ISO 14001 management system consulting and quality and production workflow software for your organization.
Together, we review your operations and requirements to build a document system suited to actual work within your organization.
From audit preparation and follow-up to document updates and improvement after process or organizational changes, we focus on a system your team can keep using in daily operations.
Your organization can choose consulting and software independently according to its needs.
Q-Maison supports ISO 9001 quality workflows.
The standards and markets covered by consulting are distinguished from product features.
Medical device regulations,
adapted to your organizationRegulation, shaped to your organization
Quality principles,
built into everyday workQuality systems, shaped to your operations
Start Here
Start with a gap assessment comparing your product and available evidence with regulatory requirements.
Tell us your current stage and the help you need, and we will define the evidence to review and the scope of support.
Start Here
Start with a current-state review comparing your documents and actual operations with requirements.
Tell us about your certification preparation or the work you want to improve, and we will define the review and support scope.
Select a stage to prepare an inquiry email for that stage.
Q-Suite offers three products you can choose according to your work.
Q-Atelier supports ISO 13485-based medical device quality and workflow management, Q-Maison supports ISO 9001 quality management, and Q-Carnet supports DHR manufacturing records and production management.
Bespoke is available for all three products.
Define the scope from forms, approvals and permissions to additional features, cross-product data integration and dedicated system development.
Customer-hosted servers and connections to existing or MedQraft-hosted databases are reviewed for your environment.
Operations and maintenance are scoped for each project.
The pharmaceutical QMS is currently in development.
Q-Suite are three products you can choose according to your work.
Q-Maison supports ISO 9001 quality management, and Q-Atelier supports ISO 13485-based medical device quality and workflow management, Q-Carnet supports DHR manufacturing records and production management.
Bespoke is available for all three products.
Define the scope from forms, approvals and permissions to additional features, cross-product data integration and dedicated system development.
Customer-hosted servers and connections to existing or MedQraft-hosted databases are reviewed for your environment.
Operations and maintenance are scoped for each project.
The pharmaceutical QMS is currently in development.
Consulting, Q-Suite and tailored systems.
Together, we design the support and systems needed for development, regulatory, quality and production work.
ISO management system consulting, Q-Suite and tailored systems.
Supporting audit preparation alongside daily quality and production work.