MED-DEV Global Solutions
Consulting firm providing regulatory, quality system, and product development support for medical device companies. Services cover global regulatory submissions and market access, quality management system design and implementation, design verification/validation (including software and human factors), audits and remediation, and distributor qualification. Headquartered in Minneapolis and operating globally since 2003.
Industries
Nr. of Employees
small (1-50)
MED-DEV Global Solutions
Minneapolis, Minnesota, United States, North America
Services
Regulatory strategy and preparation of submissions for major global regulatory pathways and markets; support for local licensing and representation.
Development and implementation of QMS aligned with applicable regulations and standards, including SOPs and training course management.
Support for verification and validation activities, including software validation and usability testing to demonstrate device performance.
Internal and supplier audit program development, gap analysis, and remediation planning/implementation.
Identification and qualification of distribution partners and execution of due diligence for market entry.
Regulatory strategy and preparation of submissions for major global regulatory pathways and markets; support for local licensing and representation.
Development and implementation of QMS aligned with applicable regulations and standards, including SOPs and training course management.
Support for verification and validation activities, including software validation and usability testing to demonstrate device performance.
Internal and supplier audit program development, gap analysis, and remediation planning/implementation.
Identification and qualification of distribution partners and execution of due diligence for market entry.
Expertise Areas
- Global regulatory affairs and submissions
- Quality management systems (ISO 13485, FDA QSR, MDSA, MDR)
- Design verification and validation (including software)
- Usability / human factors and risk management
Key Technologies
- Design verification and validation methods
- Software validation for medical devices
- Usability / human factors evaluation methods
- Quality management system implementation