Auditing- international - Import export

CIC will be happy to support you in planning, securing, controlling, monitoring and optimizing your quality management, e.g. with: advanced quality planning supplier quality purchased part quality component qualification product engineering Supplier Audit Internal audits Process monitoring and process optimization Production control and monitoring at the supplier bottleneck coordination production readiness tool design Tool tracking mold trials Gauge concepts and gauge acceptance component measurements Resident Engineering Task Force Abbreviations such as APQP, PEP, FMEA, PPAP, 8-D, 5Why are not foreign words for us but common tools.

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