Global Excellence in Delivery Device Testing

Introduction There is a need for a fully-informed laboratory in combination device validation services. The ideal is a laboratory that understands both the pharmaceutical and medical device requirements; from extractables and leachables, through bioavailability, to dose accuracy and ease of use. A good pre-clinical partner/test facility, such as Medical Engineering Technologies Ltd. (MET, www.met.uk.com) can provide regulatory guidance and Design Validation Testing (DVT) to help assist in getting a product to the marketplace. The process of generating performance and safety data should be planned to ensure efficient project management and to help reduce costs. Design Validation Planning The pre-requisites to developing a design validation programme are: Competitor submissions review Design inputs / targeted product performance European and/or FDA Guidance review Risk analysis ISO /EN /ASTM/ ICH/ pharmacopeia standards review (If this is a first foray into combination devices) A gap analysis of the Quality Managements System (QMS) and production processes and qualifications in place. A review of existing product standards and Guidance, along with detailed risk analysis, is essential to defining test programmes. This approach ensures that all the necessary testing has been carried out, and can also reduce any unnecessary testing. Additionally, the key performance requirements must be identified in a product review; this includes design inputs and a literature review. To assi...
Source: Mass Device - Category: Medical Devices Authors: Tags: Sponsored Content Medical Engineering Technologies Source Type: news