Mandava Associates provides assistance to small, medium, and large companies in dealing with FDA in accordance with the FDA guidelines for medical devices. Some of the services covered under this section include:

	FDA Medical Devices
	Analytical Chemistry
	Clinical trials management
	Compliance and enforcement
	Data development and evaluations
	Device establishment registrations and product listings
	Device master files
	GMP and GLP compliance, audits, and inspections
	Investigational device exemptions
	ISO 9000 programs and EN 46000 standards
	Medical device reporting and adverse effects
	Labeling and advertising
	Premarket notification-510(k)
	Premarket approvals (PMA)
	Regulatory strategic planning and device design
	Toxicology and safety assessments
	U.S. representation before FDA