THE COMPANY
Bureau Veritas looks back on more than 190 years of experience, and nowadays is one of the world’s leading companies in the field of Testing, Inspection and Certification (TIC). By the trust of about 400,000 customers worldwide Bureau Veritas has become what it is today: an international, professional, and successful service company with more than 80,000 employees in about 1,600 locations and over 140 countries.
SCHWERIN
Founded in 1994 in Schwerin, Germany, the site is a highly specialized testing laboratory within the Bureau Veritas CPS global network. Herein, we are focused on complex and highly regulated industries such as medical devices. These industries require both technical and professional expertise. With our knowledge, we play a key role in risk management as well as performance improvement.
The benefits to our customer are not only innovative test methods but also a wide scope of identifiable substances with competitive quantification. With our state-of-the-art technologies and newly commissioned laboratory we are ready for you!
INTRODUCTION
REGULATORY INFORMATION
The market of medical devices is highly regulated. In the European Union (EU), the Medical Device Regulation (MDR) is applied, the US devices are regulated by the Food and Drug Administration (FDA). In this regard, both MDR and FDA define its own requirements for medical devices and associated testing to which manufactu- rers must comply with.
A quality management system with risk management is required to offer medical devices within EU market. Harmonized standards such as ISO 13485 and ISO 14971 are often used to fulfill these requirements.
According to the MDR, manufacturers are obligated to systematically evaluate and record the risk emerged for medical devices. In this context, general safety and risk aspects can be managed by application of ISO 14971 and ISO 10993. Herein, the ISO 10993 series of standards focuses on biocompatibility for biological and chemi- cal properties and patient safety of the considered devices. Thus, for device manu- facturers to understand the chemical properties in order to assess risk, BV-Schwe- rin provides an outstanding analytical service using the latest techniques. For more details see on the following pages…
Bureau Veritas Consumer Products Services Germany GmbH
Mettenheimerstraße 12/14,
19061 Schwerin,
Germany
