About us
senetics is your one-stop-shop for contract development, testing, inspection and approval
of medical devices. All tasks - from the development of innovative devices, applications
and assemblies, as well as their prototyping up to series production - can be successfully
implemented. The portfolio is rounded off by competencies in the areas of regulatory
affairs, approval according to MDR/FDA, standard-compliant technical documentation,
the establishing of a quality management system and laboratory tests and inspections.
senetics accompanies you from the first innovative idea to market success!
senetics is certified according to the internationally valid quality management standard
ISO 13485 and includes a GLP (Good Laboratory Practice) testing laboratory for medical
devices. In addition, senetics works according to the international GMP (Good
Manufacturing Practice) specifications and ISO 17025. senetics is a authorized consulting
company at go-inno (Federal Ministry for Economy and Climate Protection). Likewise,
senetics is a member of the Bavarian Environmental and Climate Pact and the Bavarian
Family Pact and implements measures for this.
Our Services:
Consulting: Regulatory Affairs, Technical Documentation, Quality Management & Risk Management, Strategy & Business Expansion.
BioLabs: asepsis ,biocompatibility ,clean room monitoring, cleaning & sterilization validation, antimicrobial efficacy, custom testing
Testing laboratory: Verification, Product safety, Improvement product shelf life, Optimization
product properties, risk minimization, documentation testing
Product development: medical devices, electromedicine, therapeutic devices, drug applications, prosthetics & implants, wearables & smart sensors
Manufacturing: series production supply chain management, supplier & test equipment management, process control, traceability, quality assurance
Academy: Biological requirements, development & documentation, management, marketing & sales, qualifying further training, legal requirements,
Regulations & Standards, https://senetics.de/akademie/
NeZuMed:
The goal of our network is to establish an innovative supplier and development organization in medical technology. Through close contact with medical technology "in-market" suppliers, SME companies are enabled to establish themselves as development partners in the interdisciplinary market of medical technology on a long-term and sustainable basis. https://nezumed.de/
Contact us!
+49 981 9724 795-0 or info@senetics.de