Regulatory Experts for Medical Devices | YES Medical Device Services

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! Based on decades of practical industry experience, extensive know-how and our knowledge advantage, we can support you very efficiently and pragmatic in preparing the necessary documentation for your products and processes.

We manage

All risk categories including In Vitro Diagnostics and active medical devices
Combination products (medical devices with a pharmaceutical active ingredient)
Software

Our goal

CE marking of your medical devices for the European market
International registrations (e.g. 510(k) for USA)
Quality Management System in accordance with ISO 13485

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.

Product classifications
Demarcation expert opinion (e.g. borderline medicinal product/medical devices)
Regulatory and certification strategies
Technical Documentation (in accodance with the MDR or STED according to IMDRF)
- Clinical Evaluations
- Assessment of biocompatibility
International regulatory documentation (e.g. for USA, Canada)

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 and maintaining your vigilance system. So that you report the right things to the proper authorities at the appropriate time.