Enqual
Enqual LLC is a company dedicated to helping medical device and combination pharmaceutical product companies get to market faster and achieve true quality. They provide compliance solutions, guidance in product development, quality management systems, and support throughout the product realization process. With over 30 years of experience, Enqual offers services including design control, risk management, standards management, requirements management, training, independent reviews, EU MDR support, and product development support. They serve clients in the medical device industry, supporting various products such as central venous catheters, parenteral drug delivery systems, ultrasonic surgical instruments, IVD clinical chemistry devices, orthopedic implants, automated immunohematology analyzers, electro-mechanical-fluidic devices, extracorporeal photopheresis systems, tangential fluid flow cassettes, nylon pleated filters, and purified water systems.
Industries
Nr. of Employees
small (1-50)
Enqual
Services
Advisory services for regulatory planning, EU MDR transition strategies, and alignment to FDA and international regulatory requirements.
Creation and execution support of verification and validation plans, test method validation, and V&V documentation for device development and DHF.
Implementation and remediation of risk management systems and design control activities including HHA, post-market hazard analysis, and design inputs/outputs management.
Root cause analysis, CAPA coaching and implementation, statistical trend analysis, and remediation planning for product and process nonconformities.
Assessment and validation planning/execution for purified water and water-for-injection systems and associated laboratory and facility equipment (IQ/OQ/PQ).
Systems integration leadership for multi-subsystem projects, management of third-party suppliers, and resolution of system-level interoperability issues.
Advisory services for regulatory planning, EU MDR transition strategies, and alignment to FDA and international regulatory requirements.
Creation and execution support of verification and validation plans, test method validation, and V&V documentation for device development and DHF.
Implementation and remediation of risk management systems and design control activities including HHA, post-market hazard analysis, and design inputs/outputs management.
Root cause analysis, CAPA coaching and implementation, statistical trend analysis, and remediation planning for product and process nonconformities.
Assessment and validation planning/execution for purified water and water-for-injection systems and associated laboratory and facility equipment (IQ/OQ/PQ).
Systems integration leadership for multi-subsystem projects, management of third-party suppliers, and resolution of system-level interoperability issues.
Expertise Areas
- Quality management systems optimization (ISO 13485, QSR)
- Regulatory strategy and compliance (FDA 21 CFR 820, EU MDR)
- Design control and DHF remediation
- Verification and validation planning and execution
Key Technologies
- Design of Experiments (DOE)
- Statistical analysis and Gage R&R
- IQ/OQ/PQ validation protocols
- Risk management per ISO 14971
News & Updates
LISTEN TO MY GLOBAL MEDICAL DEVICE PODCAST WITH JON SPEER
Highlights include the story behind Enqual, product development, design controls, and best practices.
Working Remotely Best Practices: Overview
A downloadable PDF providing tips for working remotely effectively.
10 Principles of effective Teamwork
A downloadable PDF outlining principles for effective teamwork.
LISTEN TO MY GLOBAL MEDICAL DEVICE PODCAST WITH JON SPEER
Highlights include the story behind Enqual, product development, design controls, and best practices.
Working Remotely Best Practices: Overview
A downloadable PDF providing tips for working remotely effectively.
10 Principles of effective Teamwork
A downloadable PDF outlining principles for effective teamwork.