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
222 South Ninth Street, Suite 1600, Minneapolis, MN 55402
Products
Worldwide Regulatory Submissions
Consulting service for preparing and submitting medical device regulatory filings across multiple global markets.
Medical Device Establishment/Business License Consulting
Advisory service for obtaining medical device establishment and business licenses in Asian markets.
Quality Management System Development and Implementation
Service to develop and implement quality management systems compliant with international medical device standards and regulations.
Scientific and Technical Analysis and Support
Consulting service providing scientific and technical evaluation to support medical device regulatory and quality activities.
Audit Development and Implementation
Service to develop and conduct internal and supplier audits with remediation action planning for medical device companies.
Training Management for Regulatory and Quality Standards
Management and delivery of training programs related to ISO 13485, MDSAP, MDR, FDA QSR, and internal procedures for medical device companies.
Worldwide Regulatory Submissions
Consulting service for preparing and submitting medical device regulatory filings across multiple global markets.
Medical Device Establishment/Business License Consulting
Advisory service for obtaining medical device establishment and business licenses in Asian markets.
Quality Management System Development and Implementation
Service to develop and implement quality management systems compliant with international medical device standards and regulations.
Scientific and Technical Analysis and Support
Consulting service providing scientific and technical evaluation to support medical device regulatory and quality activities.
Audit Development and Implementation
Service to develop and conduct internal and supplier audits with remediation action planning for medical device companies.
Training Management for Regulatory and Quality Standards
Management and delivery of training programs related to ISO 13485, MDSAP, MDR, FDA QSR, and internal procedures for medical device companies.
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