Services
Regulatory, Quality and Compliance Initiatives
We define and execute complex pre-market applications in the USA and abroad, including communication with regulatory bodies. We provide a sound framework for establishing a compliant Quality Management System (QMS) which is an essential requirement for commercialization of approved and cleared products. The installed QMS which supports US and Outside US (OUS) incentives is aligned with FDA and ISO requirements. Some of the most challenging compliance issues facing medical device companies are found in the post-market setting including resolution of audit findings such as FDA 483 citations, Warning Letter and Consent Decree and ISO 13485 non-conformance observations. In this area, our goal is to resolve such issues while maintaining business continuity. Our expertise is inclusive of all essential Quality System elements with efficient approach to areas that traditionally bring regulatory actions against companies when mishandled. We approach governance using the principles of risk management and appropriate union of the QMS with the business management system to create efficient operations.
Strategic Planning and Product Development
We assist clients in development of a focused strategic vision, product definition and sound development plans to meet commercial needs. We use an available cohort of consultant experts with a wide range of knowledge related to medical devices, in vitro diagnostic devices (IVDD), and expertise in point of care testing (POCT). Sound technology must yield accurate and precise results for a successful medical product. We can outline an effective transition from research prototypes to robust products that can be manufactured efficiently. Adherence to Product Development and Design Control standards ensures appropriate product specifications, successful product development and product life cycle management which meets regulatory standards to support clear and complete pre-market applications.
Clinical Validity and Marketplace Application
Through a network of recognized clinical and laboratory experts we define sound clinical study approaches to product evaluations required for regulatory filings and demonstration of medical value using the principles of evidence based medicine. A good product must be useful in the hands of healthcare professionals yielding diagnostic data upon which informed medical decisions can be made, often in an urgent manner. We help successful medical device companies develop key opinion leaders (KOLs) and clinical investigation partnerships to demonstrable clinical utility in the intended use environment.