Our experienced team from a variety of scientific disciplines guarantees a quick, flexible, individual and professional project management that enables you to bring your products to market faster! Our core competencies consist of providing expert advice, offering solutions, and implementing your ideas and objectives during the entire lifecycle of your products.
You only have limited capacities to efficiently cope with the daily increasing regulatory requirements? Based on decades of practical industry experience, extensive know-how and our knowledge advantage, we can support you very efficiently in preparing the necessary documentation for your products and processes. If you wish, we can also assume the daily maintenance, so that you are always well prepared for audits or visits by government agencies or authorities!
► All risk categories including In Vitro Diagnostics
► Active and non-active medical devices
► Combination products (medical devices with a pharmaceutical active ingredient)
► CE marking of your medical devices for the European market
► International registrations
► Quality Management System in accordance with ISO 13485
EU & WORLDWIDE
With our international team of specialists, we pave the way to a CE mark for the European market as well as the international registration of your medical devices. Time is money: you can only sell products that have been approved!
► Product classifications
► Demarcation expert opinion (e.g. borderline medicinal product/medical devices)
► Regulatory and certification strategies
► Means for attaining CE mark
► Smart documentation strategies for worldwide registrations
► Essential requirements checklist
► Clinical evaluation
► Report for software validation
► Assessment of biocompatibility
► International regulatory documentation (e.g. for USA, Canada)
► Communication with authorities and notified bodies
We are your partner in the implementation of a quality management system in accordance with all regulatory requirements, or in the updating and optimization of your existing system. An efficient quality management system helps to optimize processes and, for many medical devices, forms the basis for product registration and safe products.
► Implementation of a quality management system in accordance with ISO 13485
► Updating and optimizing your quality management system
► Procedures (SOPs) and work instructions
► Combination of GMP and ISO 13485
► Internal audits and supplier audits
We maintain your technical documentation / registration documentation and keep your authorizations up to date. So you are always prepared for audits and government agency visits.
► Updating your technical documentation
► Review and analysis of the current regulatory requirements
► Standards research
► Literature research
We will inform you through active market monitoring (for example, literature monitoring) in good time of critical literature and incidents involving similar products. This way, you will be able to respond immediately and responsibly. We support you in handling incidents or building your vigilance system in accordance with MEDDEV 2.12.-1. So that you report the right things to the proper authorities at the appropriate time.
► Active market observation
► Regular systematic literature surveillance
► Medical device observation and notification systems, vigilance (also for clinical trials)
► Regulatory authority notifications
► Post-market clinical follow-up