Key Competence and Experience:
EU MDR 2017/745
EU MDD 93/42/EEC
MDCG, MEDDEV, NBOG
ISO 13485
ISO 14971, ISO/TR 24971
ISO 10993
IEC 62304
Key Consultancy Services:
– Development and management of QMS conform to
ISO 13485 & EU MDR
– Creation and Maintenance of QM Documentation
– Gap Assessment
– Audit and Assessment
– Assessment of EU regulatory strategy
– Design Control
– Technical Documentation Writing
– Driving continuous improvement in areas including
Risk Management, Vigilance, Post Market
Surveillance, CAPA, Auditing, Product Released
Activities and Supplier Management