Omega Pharma International NV

• Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
  BelgiumContact the authority →

Devices placed in 25 countries

• Belgium6
• France6
• Italy6
• Czechia5
• Portugal5
• Slovakia5
• Greece4
• Hungary4
• Bulgaria3
• Slovenia3
• Spain2
• Croatia2
• XI2
• Austria1
• Cyprus1
• Denmark1
• Estonia1
• Finland1
• Ireland1
• Lithuania1
• Latvia1
• Norway1
• Poland1
• Romania1
• Sweden1

8 contacts identified

• AC
  ARTUS-ARDUISE Cécile

  PRRC
  View profile →
• DG
  DAUDE Gaelle

  PRRC
  View profile →
• PC
  PASTOR Caroline

  PRRC
  View profile →
• TJ
  TOLLEY Josephine

  PRRC
  View profile →
• TOLLEY Josephine
  Ensure that Technical documentation and EU declaration of conformity are drawn up and kept up-to-date Sign off Regulatory Affairs related non-conformities (eg Technical file discrepancies, RA procedure related non-conformities,...)
  Hidden
• PASTOR Caroline
  Compliance with Post Marketing Surveillance obligations in accordance with EU MDR Art. 10(10) Fulfillment of reporting obligations referred to in EU MDR Articles 87 to 91 Sign off Safety related non-conformities
  Hidden
• DAUDE Gaelle
  Appropriate check of the conformity of the devices, in accordance with the quality management system under which the devices are manufactured, before a device is released. Sign off Quality Assurance related non-conformities ( eg Production related findings, Out of specifications, Release/Rework/quarantine shipment, Supply, Quality Complaints) Sign off MCRM (Monthly Review of Quality Complaints)
  Hidden
• ARTUS-ARDUISE Cécile
  Sign off documentation related to investigational devices as per EU MDR Section 4.1 of Chapter II of Annex XV requirement:
  Hidden

• OPI — BE-IM-000007209
• OPI — BE-MF-000007210
• OPI — BE-PR-000007211
• DNV MEDCERT GmbH — 1 certificate — OPI
• ARTUS-ARDUISE Cécile — OPI
• DAUDE Gaelle — OPI
• PASTOR Caroline — OPI
• TOLLEY Josephine — OPI