The One-Stop-Shopping address for all CE-market related activities

1. The company BioScan BV is a test- and research laboratory, specialized in biological safety testing, microbiological evaluation and performance testing related to medical devices. BioScan started it's activities in 1989, in Groningen, than using the name Biocom. In 1994 Biocom and the Biomaterials Research Group of the University of Leiden joined their forces and constructed a completely new laboratory facility in Bilthoven under the name BioScan. Since 1998 BioScan works in close cooperation with Factory BV, a full Contract Research Organization offering clinical trial services for medical devices. These combined services support both companies challenge to guide medical device manufacturers over the most efficient track to registration and market introduction of medical devices. BioScan has a highly qualified staff, with extensive research experience in medical device technology and evaluation, knowledge of most recent developments in the regulatory and standardization field word wide, experience with a wide range of medical device testing procedures according to European (EN), American (ASTM) and worldwide (ISO) standards and directives, experience with CE-mark procedures and experience with quality systems. In addition, BioScan can offer a high level of professionalism that is realized by a network of experts. By bringing together expertise in pre-clinical and clinical areas BioScan and Factory aim a high level of quality, accuracy, competence and client oriented services. To realize this BioScan and Factory operate in compliance with GLP, GCP and ISO 9001.

2. Products and services For placing a medical device on the market a medical device manufacturer must ensure that the device will not compromise the safety of the patient or user. To cover this assurance a manufacturer has to evaluate several aspects regarding the design and construction of the device. These aspects are for instance the chemical, physical and biological properties of the device, (in case of a sterile device) the risk on infection and microbiological contamination, construction and environmental properties, and the information for a safe use of the device supplied to the customer. The manufacturer must ensure that the device achieves the performances intended by the manufacturer. In addition the manufacturer must be able to guarantee a constant quality of the product. By the combined knowledge, experience and services, BioScan and Factory can assist manufacturers through this complicated process and guide them over the most efficient track to registration and market introduction of medical devices. Some of their services are listed below:

Biological evaluation according to ISO 10993 The selection of a material for the application in a medical device is a crucial step in the design of a device. In the first place this selection should take into account the functionality of the material regarding the application and intended use of the device. In the second (but not less important) place this selection should take into account the biological safety of the material in its intended use, or in other words, the interaction between the material and the living tissue in contact with the material. To evaluate the overall biological safety ISO 10993 lists a wide range of tests evaluating the following aspects: - cytotoxicity - sensitisation - irritation - (sub)-acute systemic toxicity - chronic toxicity - local tissue reaction - heamocompatibility - carcinogenicity - genotoxicity BioScan can offer guidance in the selection of appropriate testing programs and the performance of these tests according to the ISO 10993 requirements.

Microbiologial evaluation according to ISO 10993-11, ISO 11737-1,2 and ISO 11137 The devices and the manufacturer processes of the devices must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient or user. The design must allow easy handling and, where necessary, minimize contamination of the device by the patient or vice versa during use. This covers for instance the manufacturing in appropriately controlled conditions, effective packaging and a validated sterilization process. To validate, evaluate and control these processes several standardized test systems are available: - pyrogenicity tests - bioburden estimation tests (including recovery efficiency determination) - sterility tests - packaging integrity tests - environmental bacterial, yeast mould tests BioScan can offer guidance in the selection of appropriate testing programs and the performance of these tests according to the requirements of the relevant ISO standards.

In vivo functionality studies By its broad research experience, competence in a wide field of functionality studies in animals, clinical trials and its broad network of experts and medical professionals, BioScan and Factory can offer the set-up and performance of functionality studies in animals. Next to the evaluation of the function of the device also local tissue reactions can be evaluated due to the presence of highly sophisticated histological preparation techniques for soft and hard tissues and materials and evaluation techniques as light microscopy, Transmission Electron Microscopy and Scanning electron microscopy.