KEY COMPETENCE AND EXPERIENCE:
EU MDR 2017/745
EU MDD 93/42/EEC
MDCG, MEDDEV
ISO 13485
ISO 14971, ISO/TR 24971
ISO 14155, ISO/TR 20416
KEY CONSULTANCY SERVICES:
Training and Education
SOP generation
Clinical Strategy
Post-Market Strategy
Clinical Development Plan
Clinical Investigation Planning, Conduct and Reporting
EU Clinical Evaluation Planning and Reporting
Post-Market Surveillance Plan and Post-Market Clinical Follow-up Plan
PMS-Report and PSUR
Strategic Literature research
Scientific publication