Quality Services
GlobalMed Engineering develops and reviews quality policies, procedures, and practices to comply with ISO 13485 and FDA QSRs to help you meet business requirements, obtain global certifications, and deliver quality products.   We provide in-house training of design control procedures, design history file maintenance, and change controls.

GlobalMed Engineering works with our partners to select the finest manufacturers and vendors throughout the development process.  We manage these vendors to ensure the highest quality products, documentation, and on-time deliveries.  We provide inspection methods and procedure to certify that the final product meets the design specification and user requirements, which in turn assures high quality products.

Regulatory Services
We offer regulatory compliance services for the FDA and European Notified Bodies.  We provide assistance with regulatory strategy, submission (510K/PMA/CE), FDA and notified body documents and inquiries, clinical trial support, compliance support, and sterilization development and validation.

Risk and Hazard Analysis
GlobalMed Engineering develops and reviews risk management programs for our partners.  We implement these risk management programs to be in complete compliance with ISO 14971:2007 standards.  Our risk management services include, but are not limited to, risk analysis, hazard analysis, risk mitigation, and Failure Mode and Effects Analysis (FMEA) to provide our partners with objective evidence that your product consistently meets the specified requirements.

Failure Mode and Effects Analysis (FMEA) is an easy to use and yet powerful pro-active engineering analysis to identify, rank, and mitigate potential failure points in the development of the products and processes.  GlobalMed Engineering can apply this tool to identify unacceptable operating or design risks and areas of potential improvements.

Verification and Validation
GlobalMed Engineering offers a wide range of validation and verification services to help you meet the challenge of complying with U.S. FDA requirements and European Medical Device Directives.  We provide assistance with product design verification, design validation, sterilization validation, manufacturing process validation, and other services to ensure that your product meets domestic and international quality standards.

Drawing on years of experience, GlobalMed Engineering provides confirmation that your product conforms to its intended use and that it is able to fulfill that use. We integrate risk management, verification and validation processes throughout the life cycle of your product development and manufacture to furnish you with the objective evidence that regulating agencies require for fast approvals.

For sterilization validations, GlobalMed Engineering develops protocols, selects and manages vendors, and generates reports for regulatory submissions.