Strategic Partnerships for End-to-End Regulatory Success
To provide truly integrated, end-to-end services, we collaborate with a trusted network of domestic and global affiliates. These partners extend our reach and capabilities, allowing us to tailor support across geographies and disciplines. Together, we offer seamless coordination to meet your regulatory, quality, and commercialization goals.
Service Providers
To deliver comprehensive support across every stage of the product lifecycle, we partner with specialized service providers who bring technical depth and hands-on experience. These experts complement our capabilities and help ensure efficient, compliant, and successful outcomes for our clients.
- [b]Clinical Research Organizations (CROs)[/b] – Supporting clinical strategy, trial design, execution, and data analysis.
- [b]Human Factors and Usability Engineering Experts[/b] – Ensuring products are safe, effective, and user-centered through research and validation.
- [b]Software Development and Validation Specialists[/b] – Guiding compliant development and verification of software as a medical device (SaMD) and embedded systems.
- [b]Quality System Auditors and Training Providers[/b] – Strengthening your internal processes with audits, gap assessments, and customized staff training.
- [b]Regulatory Intelligence Platforms and Legal Advisors[/b] – Providing real-time insight into evolving global regulations and expert guidance on legal compliance.
mdi Europa GmbH
mdi Europa serves as a European Authorized Representative, helping global medical device manufacturers meet EU MDR and IVDR requirements. Their experienced team has supported CE Marking for hundreds of companies, from startups to established brands.
Klass Consulting
Klass Consulting helps medical device companies enter European markets, Turkey, and Russia. Their core services include distributor identification and management, as well as reimbursement and global marketing strategy support.
Medical Equipment Compliance Association, LLC
Provides evaluation, testing, and compliance reporting for FDA, Health Canada, and international regulatory bodies, supporting CE Marking and global approvals.