BioMedica offers a number of regulatory services to our customers, including:
- USFDA 510K Registrations
- European EC1996/96: IVD Directive Conformity Registrations
- Health Canada CMDCAS Compliance Registrations
- Physician’s Office Laboratories
Specialized services include:
- Clinical Trial Sites, Medical Device Validations and Data Collection Services
- Regulatory Documentation and Submission Services
- CE Mark Technical Files Preparation and Reviews
- ISO 13485:2003, USFDA cGMP and CMDCAS, CAP/CLSI Quality Management System Development Services and Reviews
- Physicians Office Laboratory Establishment, Training and Compliance Services
- Specialized Diagnostics R&D / New Technology Validation Services
