Ivd Consultants
United States In Vitro Diagnostic Consultants is a full-service consulting firm specializing in U.S. FDA and Global Regulatory Affairs services for the In Vitro Diagnostic (IVD) Device, Companion Diagnostic (CDx) Device, Medical Device, Combination Drug/Device, Clinical Laboratory, Biological, and Pharmaceutical industries. They provide a wide range of regulatory consulting services including product submissions, approvals, compliance, clinical trial development, quality system regulation, software development process, and inspection readiness.
Industries
Nr. of Employees
small (1-50)
Ivd Consultants
Madison, Wisconsin, United States, North America
Services
Advisory and execution services to develop regulatory strategies and conduct negotiations with U.S. FDA and other global regulatory authorities for diagnostics, devices and combination products.
Preparation and compilation of regulatory submissions for U.S. and global premarket pathways including LDT documentation, IDE, 510(k), PMA, IND, NDA and BLA filings.
Design and execution support for clinical studies and protocols required to generate evidence for regulatory submissions.
Implementation and compliance services for quality systems and GxP requirements, including QSR and GMP-related activities.
Support for implementing and maintaining ISO 13485 and ISO 9001 quality management systems.
Preparation of technical files and support for CE marking and applicable EU regulatory directives for medical devices and diagnostics.
Advisory and execution services to develop regulatory strategies and conduct negotiations with U.S. FDA and other global regulatory authorities for diagnostics, devices and combination products.
Preparation and compilation of regulatory submissions for U.S. and global premarket pathways including LDT documentation, IDE, 510(k), PMA, IND, NDA and BLA filings.
Design and execution support for clinical studies and protocols required to generate evidence for regulatory submissions.
Implementation and compliance services for quality systems and GxP requirements, including QSR and GMP-related activities.
Support for implementing and maintaining ISO 13485 and ISO 9001 quality management systems.
Preparation of technical files and support for CE marking and applicable EU regulatory directives for medical devices and diagnostics.
Expertise Areas
- Regulatory affairs for in vitro diagnostics and medical devices
- Regulatory strategy and submissions (U.S. FDA and global agencies)
- Clinical trial and study protocol design and execution
- Quality systems and GxP compliance (QSR, GMP, GLP, GCP)
Key Technologies
- IEC 62304-compliant software development lifecycle
- Quality management systems (ISO 13485, ISO 9001)
- GxP frameworks (QSR/GMP/cGMP, GLP, GCP)
- Regulatory submission frameworks (510(k), PMA, IDE, IND, NDA, BLA)