Kapstone Medical

Regulatory consulting services provided by specialists holding the Regulatory Affairs Certificate (RAC) for global regulatory compliance.

A fully integrated new product development service for medical device companies, covering expertise, design, engineering, manufacturing, regulatory affairs, intellectual property strategy, and quality assurance.

ISO 13485 contract manufacturing and consultancy services ensuring international quality standards for medical devices.

Comprehensive medical device prototyping services encompassing appearance models, proof of concept, alpha and beta testing prototypes, and pilot manufacturing.

A comprehensive contract manufacturing solution handling fabrication, assembly, packaging, labeling, sterilization, and logistics for medical devices.

Full lifecycle support for medical device quality assurance, including QMS setup, remediation, off-the-shelf systems, and ISO 13485 certification assistance.

Back office support services in functional areas including Engineering, Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Logistics and Distribution, and Operations.

Comprehensive Quality Management System (QMS) development, implementation, maintenance, and training services for medical device companies.

Best-in-the-industry supply chain management services ensuring every production step is optimized for efficient delivery and regulatory compliance.

Comprehensive medical device testing services including initial testing and analysis, design verification, design validation, and process validation to support regulatory submissions.

Manufacturing engineer resources that integrate to provide DFX, design for manufacturing, and design for assembly services.

Product development engineering services utilizing certified SolidWorks CAD platform proficiency at the Professional level in Mechanical Design.

Human factors engineering and usability evaluation services including early-stage formative studies and FDA-compliant summative validation testing.

Medical device product and company launch services including business strategy, market entry support, product launch support, and ongoing operational support.

Quality engineering and documentation support services for new medical device development, including building Design History Files (DHF) and managing quality documentation before regulatory submission or market launch.

Medical device human factors engineering and user research services to define the context of use and align HFE scope with indications for use.

Compliance remediation consulting and program development services to help medical device companies detect, prevent, and remedy non-compliant activity and prepare for regulatory audits.

Comprehensive auditing services for medical device companies to help create documented processes, conduct internal audits, and prepare for FDA inspections and ISO 13485 audits.

Industrial design and UI/UX services ensuring physical and digital interfaces are intuitive, safe, and professional for medical devices.

Expert consultation and support services for medical device product launches, including design transfer, inventory build, regulatory compliance, and operational support.

Conducting gap analysis for medical devices to evaluate regulatory compliance against major standards such as US FDA QSR, EU MDR, EU IVDR, and Health Canada Medical Devices Regulations.

Annual FDA establishment registration compliance services and support for medical device production and commercial distribution.

A comprehensive Quality Management System offered in modular versions including Lean Starter, Starter, Production, Software Development, EU MDR, MDSAP, and Electronic Records, compatible with both paper-based and electronic platforms.

Assistance with key regulatory aspects of launching products, importation requirements, and U.S. Representative services.

Medical device business strategy and market entry consulting services for OEMs, assisting companies with market research, business model selection, and cost modeling.

Provision of skilled Quality Engineering or Quality Assurance resources for product development projects or internal quality departments.

Transition services and consulting for implementing an electronic quality management system (eQMS).