The Halper Group offers a variety of services:   Quality System Regulation (CGMP) Compliance audits and recommendations training for management, technical staff, and line personnel responses to FDA 483 reports and Warning Letters   ISO 13485 and ISO 9001 audits and gap analyses training for your company and its suppliers assistance in achieving certification   The European Directives practical advice to achieve conformity writing technical files and design dossiers Implementing and maintaining your Quality System assistance in developing procedures training/workshops on design control training/workshops on process validation training/workshops on internal and supplier auditing writing validation protocols and reports statistically-based inspection and SPC Premarket Notifications Determining when a 510(k) is needed Assistance in writing and submitting 510(k)'s