Medical Devices & IVDs

International development and marketing of medical devices require expert level navigation of the regulations and directives to prevent bottlenecks and to minimize risk.

Together with our global partners, we are able to bring to you comprehensive medical device consulting, to help streamline the registration and submission processes to save you time and money.

We offer the following medical device regulatory services:

Clinical Product Development

Medical device strategy development
Assistance with creation of product development plans
Clinical Trial Dossiers
Investigational Device Exemption (IDE) Applications
Development of clinical and non-clinical trial protocols
Medical writing/CSRs

Global Regulatory Affairs Support

US Agent, EU or UK Responsible Person Services
Training on global regulatory compliance for medical devices
Authorized representative/Agent in the United States, Canada, Europeans Union, Latin America, Asia-Pacific, MENA, South Africa
Global regulatory intelligence for licensing, registrations, renewals, labeling, and on-going updates

International Regulatory Documentation Submissions

FDA 510(k) Submissions/Pre-Market Approval (PMA)
EU MDR Compliance, Technical Files, CE Marking
Ex-US Device/IVD registrations
License renewals; including registrations & certifications
Facility Registration & Device Listing

Quality Assurance, Auditing & Inspections

GMP/ISO 13485 compliance
Medical Device Single Audit Program (MDSAP)
Risk management auditing
Evaluation of quality systems and processes
Process validation, cleaning validation, equipment validation and technology transfer