MDR Techninė Dokumentacija
Our experienced team has for years done documentation for companies who are manufacturers of medical devices /surgical instruments. We provide Quality-Management-Systems for meeting legal and normative requirements.
For manufacturers of medical devices / surgical instruments class I (including Is, Im, and new for MDR class Ir), IIa, and IIb we offer the following services:
Implementation DIN EN ISO 13485 and the EU-Regulation 2017/745 MDR and 21 CFR 820 QSR
Creating QM-Systems with procedural instructions and work instructions
Technical Documentation
Clinical evaluation
Risk Management / Risk Analysis
Essential Safety and Performance Requirements
Validation of processes
UDI-labeling
Consulting for Regulatory Affairs
Internal audits and external supplier audits
Accompaniment and support with inspections by authorities and Audits by notified bodies
Communication with authorities