ViVitro can perform a literature review to support the development of a specific device. This can used to build a rational as requested by the client.
The literature search will be focused on the most recent published articles. Specific requirements for the study will have to be provided by the customer.
Test parameters and acceptance criteria can be derived using engineering expertise in physiology, biomechanics and fluid mechanics complemented by references from publications. Literature search is used to identify, rationally select, and collect pertinent information in relation to specific technical, design, pre-clinical and clinical issues. Literature search is conducted in a way that the method used can be scrutinized by third party reviewers, results provided can be verified, and the search can be repeated and reproduced if required.
ViVitro uses a Standard Operating Procedure in compliance with MEDDEV. 2.7/1 section A4 and A5 to properly identify publications database, information sources, and proper key words. Then a process is used screen and select the specific documents used to develop and build the rational. ViVitro has developed a proprietary process to search articles from more than 40 databases around the world and provide customers with most up to date references. Test parameter rationalization can be integrated into any design specification documents, acceptance criteria can be derived from FMEA study.
Any cardiovascular device.
MEDDEV 2.7/1 Revision 4BS EN 13868:2002
Medical Devices Directives – Clinical Investigation Clinical Evaluation: A guide for manufactures and notified bodies under directives 93/42/EEC and 90/385/EEC
ViVitro Labs Advantages
Many companies look to academia to handle their testing needs due to the reduced cost. With ViVitro Laboratory Services you gain the following advantages:
Time to Market
We understand how critical your timelines are. Our expertise and experience ensure your schedule is met and our commitments are delivered on time.
Free Initial Consultations
All of our studies are scoped via no-cost, no obligation, collaborative consultation.
We happily provide Non-Disclosure Agreements for all services, including initial consultation.