Regulatory Compliance Services
During the product development and product updates, the continuous check and adation of the regulatory strategy and adaption to changed laws and standards is neccessary. Our services:
Our Services
Riskmanagement:
The basic approach in CE marking allows manufacturers a great deal of freedom, up to and including self-declaration of conformity. Conversely, manufacturers bear a high degree of direct responsibility, which they must fulfill for regulatory and liability reasons. In the CE certification of medical devices, systems and processes for the area of risk management are specified by the international standard EN ISO 14971. The content of this standard refers to the various procedures for managing risks posed by medical devices to patients, users, other persons as well as the environment and equipment. With our expertise, we continuously support you in all phases of compliance with the EN ISO 14971 standard.
Our service starts with the planning and development of a risk management system tailored to your needs, and extends through implementation to maintenance, and also includes the establishment of an appropriate documentation system.
CE Marking:
We have already successfully supported a large number of medical device manufacturers in meeting the requirements for CE certification and thus enabling market access within the European Union.
Through our contact with Notified Bodies, we know exactly what the requirements are and how the processes work. Thus, we can plan and implement appropriate approval strategies. Thanks to our many years of experience, we can support you in the market access of your products in order to accelerate this process in the best possible way and to implement the conformity assessment procedures that are suitable for you.
CE marking in compliance with the European Directives for Medical Devices 93/42/EEC and 90/385/EEC for Active Implants ensures broad access for your product to EU and EFTA countries.
In addition, a marking based on sound Technical Documentation is a strong and reliable basis for the approval and classification of your medical device in many countries outside (and within) the European Union.
Memberships
Call: +49 9123 1529250
Mail: info@be-on-quality.com
Office adress, Visitors adress, Büroanschrift:
be-on-Quality GmbH
Bahnhofstrasse 85
91233 Neunkirchen am Sand
Headquarter of be-on-Quality GmbH
Lilienstrasse 33, 91244 Reichenschwand