Authorized Representation for Europe: European Medical Device Directives require the appointment of an Authorized Representative for Europe. DTA members may purchase this service at a discounted rate of $1,800 per annum.

Consortium Services: DTA and EMERGO mutually agree that implementation of ISO standards within the medical device arena is a critical marketing, productivity and efficiency advantage, especially as it relates to the regulatory requirements for certain geographic areas such as Canada and Europe. The Consortium service provides small to medium sized companies the opportunity to implement and manage an ISO based quality management system in a cost efficient manner requiring a minimum of 5 companies participating in this structured combined classroom and on site instructional environment. To that end, EMERGO offers this service to DTA members at a reduced cost of $11,900 per each company enrolled.

ISO Implementation - Stand Alone: DTA members may opt to select the implementation of a Quality Management System independently of our Consortium Services product. For the duration of this agreement, EMERGO agrees to "freeze" the gross daily rate to $1,200 per day. ISO Implementations generally require 15 to 20 days of our time for effective implementations.

GAP Analysis: Often companies need to first understand where they stand with regards to their particular needs when planning their implementation of a Quality Management System. This requires a minimum of two days of work and reporting. The minimum fee offered to DTA members would be $2,400.00.

510(k) Preparation and Submission: We anticipate that most 510 (k) preparations and submissions will require 5 days worth of work. In each case where this is anticipated, EMERGO will provide this service for DTA members at a flat rate of $5,000 per submission if a similar predicate device can be identified. The fee may be higher in those cases where there is no predicate device.

PMA's: The preparation and submission of PMA's can often be complex and lengthy in nature. EMERGO will provide this service for members of DTA at a rate of $1,200 per day.

Contractor/Vendor Audits: ISO certified members of DTA, or firms meeting FDA GMP's may utilize outside vendors and contractors in the performance of manufacturing, raw materials, services, etc. as necessary for the member to perform their business. Often these vendors should be audited from time to time by the member company to insure compliance with or possession of good quality management systems to support the work of the member company. EMERGO will provide outside audits to member companies of the DTA at a rate of $1,200 per day.