Irwin & Associates
Irwin & Associates, Inc. is a medical device consulting firm dedicated to supporting companies throughout all stages of product development and lifecycle. They provide expert consulting services in areas such as Quality Engineering, Regulatory Strategy, Project Management, Design Control, Technical Writing, R&D, and more. Their mission is to help clients succeed by delivering technical support, innovative solutions, and attention to detail, fostering success together.
Industries
Nr. of Employees
small (1-50)
Irwin & Associates
Pleasanton, California
Services
Contract consulting engagements providing subject-matter expertise across quality engineering, regulatory strategy, design control, verification/validation, and R&D.
Project management services for medical device product development and lifecycle management.
Operational consulting services to support process and organizational improvements.
Advisory services focused on corporate strategy and business planning for medical device organizations.
Contract consulting engagements providing subject-matter expertise across quality engineering, regulatory strategy, design control, verification/validation, and R&D.
Project management services for medical device product development and lifecycle management.
Operational consulting services to support process and organizational improvements.
Advisory services focused on corporate strategy and business planning for medical device organizations.
Expertise Areas
- Quality management
- Design control and requirements management
- Regulatory strategy and submissions
- Project management for medical devices
Key Technologies
- Quality Management Systems (QMS)
- Design control and requirements traceability
- Verification & validation methodologies
- Software validation practices
News & Updates
Interview with Barbara Allen, discussing success in the medical device industry.
Barbara Allen shares her journey and insights on finding a dream job and supporting medical device companies.
Irwin & Associates Inc. recognized as one of the ‘Best Medical Device Consultancy Services Company’ in 2021.
Irwin & Associates has provided consulting support to the medical device and biotech sectors for 22 years.
Interview with Barbara Allen, discussing success in the medical device industry.
Barbara Allen shares her journey and insights on finding a dream job and supporting medical device companies.
Irwin & Associates Inc. recognized as one of the ‘Best Medical Device Consultancy Services Company’ in 2021.
Irwin & Associates has provided consulting support to the medical device and biotech sectors for 22 years.