Cook Device Solutions
Cook Device Solutions is a consulting firm dedicated to delivering compliant results in the medical device industry. They specialize in navigating complex regulations and standards, offering hands-on execution and training to ensure high levels of regulatory compliance and sustainability for their clients. Their services include quality and regulatory consulting, compliance for manufacturing and marketing, and support for startups and established businesses to build internal teams and maintain compliance.
Industries
Nr. of Employees
small (1-50)
Cook Device Solutions
Indianapolis, Indiana, United States, North America
Services
Quality and regulatory consulting
Advisory and hands-on support across QMS, regulatory strategy, standards compliance, and audit remediation for medical device organizations.
Engineering support and design control implementation
Support for design controls, DHF/DMR preparation, risk management, verification/validation planning, and technical file generation.
Regulatory registration and submission support
Preparation and filing support for regulatory registrations and device licensing in jurisdictions including the US, EU, Canada, Brazil, Australia, and Japan.
Validation, qualification, and testing support
Development and execution of IQ/OQ/PQ, process validation, software validation, and cleanroom validation protocols and reports.
Facility relocation, startup and commissioning support
Project support for facility moves, new facility start-ups, commissioning, and qualification to ensure continuity of compliant operations.
Business development and M&A due diligence
Operational reviews, costing methodology implementation, M&A compliance audits, and acquisition readiness assessments.
Quality and regulatory consulting
Advisory and hands-on support across QMS, regulatory strategy, standards compliance, and audit remediation for medical device organizations.
Engineering support and design control implementation
Support for design controls, DHF/DMR preparation, risk management, verification/validation planning, and technical file generation.
Regulatory registration and submission support
Preparation and filing support for regulatory registrations and device licensing in jurisdictions including the US, EU, Canada, Brazil, Australia, and Japan.
Validation, qualification, and testing support
Development and execution of IQ/OQ/PQ, process validation, software validation, and cleanroom validation protocols and reports.
Facility relocation, startup and commissioning support
Project support for facility moves, new facility start-ups, commissioning, and qualification to ensure continuity of compliant operations.
Business development and M&A due diligence
Operational reviews, costing methodology implementation, M&A compliance audits, and acquisition readiness assessments.
Expertise Areas
- Quality management system implementation and compliance
- Regulatory submissions and global device registration
- Design controls and medical device engineering
- Verification, validation, and qualification (IQ/OQ/PQ)
Key Technologies
- ISO 13485-based QMS implementation
- Risk management per ISO 14971
- IQ/OQ/PQ protocol development
- Software validation for regulated systems