Biodevice Solutions

regulatory, quality and operations management consultants to the medical device industry. specialties: *food and drug administration, cdrh; notified bodies, bsi, tuv, lrqa, nsf; compliance remediation *510(k), ide, pma, pdp, 513(g), etc. submissions *design controlled product development programs; *medical device classification determinations; *customized qsr program installation, auditing and corrective action programs; *interim ra/qa and operational p/l management; *regulatory / technical due diligence for m&as; *recall determinations, strategy and management; *risk assessments, product and business; *complaint, mdr, capa, design control management *fda 483 inspections; warning letters, consent decree, responses and remediation programs; *our partnerships include leading scientific, research&development;, manufacturing, testing and legal organizations.