|• Advice on ISO 13485:2003 certification and respective QMS audits.
• Regulatory advice (MDD 93/42/EEC, 90/385/EEC, 98/79/EC).
• Documentation relevant for Conformity Assessment.
• Management of biocompatibility studies according to ISO 10993.
• Design and management of clinical trials (GCP, ICH, ISO 14155).
• Clinical Evaluations according to MEDDEV 2.7.1.
• Negotiations with authorities and Notified Bodies.
• Scientific reports.
• Training and qualification courses and seminars.